Company ยท US
Casco Standards
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1998. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 15 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 10 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| DIF | Drug Mixture Control Materials | 3 |
| JIT | Calibrator, Secondary | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 1998 | K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 Casco Standards | JIX |
| Feb 20, 1998 | K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL Casco Standards | JJY |
| Sep 13, 1996 | K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR Casco Standards | JIX |
| Jul 22, 1996 | K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL Casco Standards | JJY |
| Jul 22, 1996 | K961750 | DOCUMENT CARDIAC ASSAYED CONTROL Casco Standards | JJY |
| Mar 22, 1996 | K960244 | DOCUMENT TDM ULTRA ASSAYED CONTROL Casco Standards | DIF |
| Dec 20, 1995 | K955155 | DOCUMENT TDM ULTRA UNASSAYED CONTROL Casco Standards | DIF |
| Apr 11, 1995 | K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET Casco Standards | JJY |
| Jan 17, 1995 | K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Dec 9, 1994 | K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL Casco Standards | JJY |
| Nov 30, 1994 | K944361 | DOCUMENT R AMMONIA/ETHANOL CONTROL Casco Standards | JJX |
| Nov 15, 1994 | K944639 | DOCUMENTR AMMONIA/ETHANOLCALIBRATOR Casco Standards | JIX |
| Nov 15, 1994 | K944338 | DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET Casco Standards | JJX |
| Apr 5, 1994 | K940568 | DOCUMENT(R) ZERO Casco Standards | JJX |
| Aug 2, 1993 | K932870 | DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Jun 29, 1993 | K932458 | DOCUMENT ENZYME Casco Standards | JJY |
| May 12, 1993 | K931139 | DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET Casco Standards | JJY |
| Jan 11, 1993 | K924493 | DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD Casco Standards | JJX |
| Nov 5, 1992 | K923821 | DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Nov 5, 1992 | K923795 | DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET Casco Standards | JJY |
| Nov 5, 1992 | K923794 | DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET Casco Standards | JJX |
| Nov 5, 1992 | K923793 | DOCUMENT CHEM III CALIBRATION VERIFICATION TEST Casco Standards | JJX |
| Feb 6, 1992 | K915792 | DOCUMENT CK ISOENZYMES CONTROL Casco Standards | CDP |
| Sep 13, 1991 | K913309 | TDM I LINEARITY TEST SET Casco Standards | DIF |
| May 10, 1991 | K910440 | DOCUMENT REFLECTANCE II LINEARITY TEST SET Casco Standards | JJY |
| Mar 29, 1991 | K910962 | CHOLESTEROL CALIBRATOR SET Casco Standards | JIT |
| May 31, 1990 | K901988 | DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET Casco Standards | JJY |
| Jan 2, 1990 | K896522 | DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY Casco Standards | JJY |
| Jul 20, 1989 | K893139 | DOCUMENT(TM) URIC ACID LINEARITY TEST SET Casco Standards | JIT |
| Jun 23, 1989 | K893142 | DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET Casco Standards | JJY |
| Jun 23, 1989 | K893141 | DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET Casco Standards | JJY |
| Jun 23, 1989 | K893140 | DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET Casco Standards | JJX |
| Dec 14, 1988 | K884197 | DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET Casco Standards | JIT |
| Oct 13, 1988 | K883861 | DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST Casco Standards | JJY |
| Jun 10, 1988 | K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET Casco Standards | JJR |
| Feb 20, 1987 | K870252 | DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET Casco Standards | JJY |
| Jun 13, 1986 | K861506 | DOCUMENT ENZYME LINEARITY TEST SETS Casco Standards | JJT |
| Oct 17, 1984 | K843947 | DOUMENT TM LINEARITY TEST STANDARDS Casco Standards | JIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||