Clinical Controls, Inc.
Hawaiian Gardens, CA, US
Clinical Controls, Inc. appears in FDA device records in Hawaiian Gardens, CA. FDA records list 18 510(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
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Clinical Controls, Inc. between 1994 and 2001. The busiest year on record is 1995, with 10. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 10 |
| 1996 | 4 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012907 | LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL | DIF | Substantially Equivalent | |
| K964278 | WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 | JJX | Substantially Equivalent | |
| K962432 | LIQUISPEX URINE (MICRO)ALBUMIN CONTROL | JJX | Substantially Equivalent | |
| K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 | JJY | Substantially Equivalent | |
| K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 | JJY | Substantially Equivalent | |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | GIL | Substantially Equivalent | |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | GIL | Substantially Equivalent | |
| K946266 | FERRITIN CONTROL - LEVEL 1, 2, 3 | DGD | Substantially Equivalent | |
| K946050 | LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 | DCK | Substantially Equivalent | |
| K946049 | LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 | JJY | Substantially Equivalent | |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | JZG | Substantially Equivalent | |
| K946144 | LIQUISPEX(TM) URINE ETHANOL CONTROL | JJX | Substantially Equivalent | |
| K946143 | CHEMSPEX(TM) AMMONIA CONTROL | JJX | Substantially Equivalent | |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | JJT | Substantially Equivalent | |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | JJT | Substantially Equivalent | |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | JJT | Substantially Equivalent | |
| K935599 | HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 | JJY | Substantially Equivalent | |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | GIL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DIFDrug Mixture Control Materials
- JJTEnzyme Controls (Assayed And Unassayed)
- DGDIgg, Ferritin, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GILPlasma, Fibrinogen Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JZGSystem, Test, Beta-2-Microglobulin Immunological
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