Casco Standards
Yarmouth, ME, US
Casco Standards appears in FDA device records in Yarmouth, ME. FDA records list 38 510(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
- 38
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 38 510(k) clearances for Casco Standards between 1984 and 1998. The busiest year on record is 1992, with 5. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 5 |
| 1993 | 4 |
| 1994 | 5 |
| 1995 | 3 |
| 1996 | 4 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 | JIX | Substantially Equivalent | |
| K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL | JJY | Substantially Equivalent | |
| K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR | JIX | Substantially Equivalent | |
| K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL | JJY | Substantially Equivalent | |
| K961750 | DOCUMENT CARDIAC ASSAYED CONTROL | JJY | Substantially Equivalent | |
| K960244 | DOCUMENT TDM ULTRA ASSAYED CONTROL | DIF | Substantially Equivalent | |
| K955155 | DOCUMENT TDM ULTRA UNASSAYED CONTROL | DIF | Substantially Equivalent | |
| K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET | JJY | Substantially Equivalent | |
| K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL | JJY | Substantially Equivalent | |
| K944361 | DOCUMENT R AMMONIA/ETHANOL CONTROL | JJX | Substantially Equivalent | |
| K944639 | DOCUMENTR AMMONIA/ETHANOLCALIBRATOR | JIX | Substantially Equivalent | |
| K944338 | DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET | JJX | Substantially Equivalent | |
| K940568 | DOCUMENT(R) ZERO | JJX | Substantially Equivalent | |
| K932870 | DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K932458 | DOCUMENT ENZYME | JJY | Substantially Equivalent | |
| K931139 | DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET | JJY | Substantially Equivalent | |
| K924493 | DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD | JJX | Substantially Equivalent | |
| K923821 | DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K923795 | DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET | JJY | Substantially Equivalent | |
| K923794 | DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET | JJX | Substantially Equivalent | |
| K923793 | DOCUMENT CHEM III CALIBRATION VERIFICATION TEST | JJX | Substantially Equivalent | |
| K915792 | DOCUMENT CK ISOENZYMES CONTROL | CDP | Substantially Equivalent | |
| K913309 | TDM I LINEARITY TEST SET | DIF | Substantially Equivalent | |
| K910440 | DOCUMENT REFLECTANCE II LINEARITY TEST SET | JJY | Substantially Equivalent | |
| K910962 | CHOLESTEROL CALIBRATOR SET | JIT | Substantially Equivalent | |
| K901988 | DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET | JJY | Substantially Equivalent | |
| K896522 | DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY | JJY | Substantially Equivalent | |
| K893139 | DOCUMENT(TM) URIC ACID LINEARITY TEST SET | JIT | Substantially Equivalent | |
| K893142 | DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET | JJY | Substantially Equivalent | |
| K893141 | DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET | JJY | Substantially Equivalent | |
| K893140 | DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET | JJX | Substantially Equivalent | |
| K884197 | DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET | JIT | Substantially Equivalent | |
| K883861 | DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST | JJY | Substantially Equivalent | |
| K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET | JJR | Substantially Equivalent | |
| K870252 | DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET | JJY | Substantially Equivalent | |
| K861506 | DOCUMENT ENZYME LINEARITY TEST SETS | JJT | Substantially Equivalent | |
| K843947 | DOUMENT TM LINEARITY TEST STANDARDS | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DIFDrug Mixture Control Materials
- JJRElectrolyte Controls (Assayed And Unassayed)
- JJTEnzyme Controls (Assayed And Unassayed)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain