Biosite Incorporated
San Diego, CA, US
Biosite Incorporated appears in FDA device records in San Diego, CA. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 46
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 46 510(k) clearances for Biosite Incorporated between 1990 and 2010. The busiest year on record is 2004, with 5. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 4 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092987 | INRATIO/INRATIO2 TEST STRIPS | GJS | Substantially Equivalent | |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | DJR | Substantially Equivalent | |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | JJY | Substantially Equivalent | |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | NBC | Substantially Equivalent | |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | JJY | Substantially Equivalent | |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | GGN | Substantially Equivalent | |
| K062530 | TRIAGE PROTEIN C TEST | GGP | Substantially Equivalent | |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | DIF | Substantially Equivalent | |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | DJR | Substantially Equivalent | |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | NBC | Substantially Equivalent | |
| K051787 | TRIAGE BNP TEST, MODEL 98000XR | NBC | Substantially Equivalent | |
| K050799 | TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS | GGN | Substantially Equivalent | |
| K050037 | TRIAGE TOX DRUG SCREEN CONTROLS | DIF | Substantially Equivalent | |
| K043242 | TRIAGE TOX DRUG SCREEN | LDP | Substantially Equivalent | |
| K042723 | TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 | DAP | Substantially Equivalent | |
| K042890 | TRIAGE D-DIMER TEST, MODEL 98100 | GHH | Substantially Equivalent | |
| K040459 | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS | JJY | Substantially Equivalent | |
| K040437 | TRIAGE PROFILER S.O.B. PANEL | DAP | Substantially Equivalent | |
| K032235 | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | NBC | Substantially Equivalent | |
| K033383 | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 | NBC | Substantially Equivalent | |
| K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL | NBC | Substantially Equivalent | |
| K030089 | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS | JJY | Substantially Equivalent | |
| K030088 | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS | JJY | Substantially Equivalent | |
| K021317 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | NBC | Substantially Equivalent | |
| K014247 | TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 | DKZ | Substantially Equivalent | |
| K012745 | TRIAGE TOX DRUG SCREEN, CATALOG #94000 | DKZ | Substantially Equivalent | |
| K013002 | TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 | DIF | Substantially Equivalent | |
| K012999 | TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 | DIF | Substantially Equivalent | |
| K010266 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 | NBC | Substantially Equivalent | |
| DEN000010 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | NBC | Unknown | |
| K000231 | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS | JJX | Substantially Equivalent | |
| K000230 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS | JJX | Substantially Equivalent | |
| K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA | MHI | Substantially Equivalent | |
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A | MCB | Substantially Equivalent | |
| K973547 | TRIAGE STATMETER | KHO | Substantially Equivalent | |
| K974827 | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE | JJY | Substantially Equivalent | |
| K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL | JJT | Substantially Equivalent | |
| K973784 | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS | DKZ | Substantially Equivalent | |
| K973126 | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I | JHX | Substantially Equivalent | |
| K955934 | TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 | DKZ | Substantially Equivalent | |
| K955935 | TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS | DKZ | Substantially Equivalent | |
| K934340 | BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS | LFI | Substantially Equivalent | |
| K931598 | BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) | LDJ | Substantially Equivalent | |
| K924476 | THE TRIAGE II | DKZ | Substantially Equivalent | |
| K914146 | BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE | DKZ | Substantially Equivalent | |
| K902924 | BIOSITE DIAGNOSTICS OPIATE SCREENING TEST | DJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MCBAntigen, C. Difficile
- LDPColorimetry, Acetaminophen
- DIFDrug Mixture Control Materials
- JJTEnzyme Controls (Assayed And Unassayed)
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- MHIGiardia Spp.
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GGNPlasma, Coagulation Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- NBCTest, Natriuretic Peptide
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain