Panels › Clinical Chemistry › Product code JIT · Class 2
Calibrator, Secondary
Regulation 862.1150
0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
Top companies in JIT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2003 | K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| Sep 30, 2002 | K022533 | FASTPACK TESTOSTERONE CALIBRATOR Qualigen, Inc. | JIT |
| Jul 22, 2002 | K022027 | CALIBRATING MATERIAL, BUFFERS, STANDARD Mission Diagnostics | JIT |
| Jun 27, 2002 | K021607 | RDI HS CRP CALIBRATOR SET Reference Diagnostics, Inc. | JIT |
| Jun 27, 2002 | K021535 | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR Bayer Diagnostics Corp. | JIT |
| Jun 27, 2002 | K021532 | ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR Bayer Diagnostics Corp. | JIT |
| Jun 21, 2002 | K020980 | DIMENSION TPSA CALIBRATOR, MODEL #RC459 Dade Behring, Inc. | JIT |
| May 8, 2002 | K020723 | DIMENSION ALDL CALIBRATOR, MODEL DC131 Dade Behring, Inc. | JIT |
| Apr 29, 2002 | K020894 | CALIBRATING MATERIAL, CAL-PAK, BUFFERS Mission Diagnostics | JIT |
| Apr 8, 2002 | K020454 | CHEMISTRY CALIBRATOR Jas Diagnostics, Inc. | JIT |
| Mar 23, 2002 | K020596 | CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS Diamond Diagnostics, Inc. | JIT |
| Dec 21, 2001 | K013850 | STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE Diamond Diagnostics, Inc. | JIT |
| Oct 16, 2001 | K012900 | ACCESS UNCONJUGATED ESTRIOL CALIBRATORS Beckman Coulter, Inc. | JIT |
| Oct 9, 2001 | K012367 | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D Nichols Institute Diagnostics | JIT |
| Sep 11, 2001 | K012233 | STRATUS CS TROPONIN I CALIBRATOR Dade Behring, Inc. | JIT |
| Aug 24, 2001 | K012399 | MODIFICATION TO ELECSYS FSH II CALSET Roche Diagnostics Corp. | JIT |
| Aug 1, 2001 | K010332 | WAKO IMMUNOASSAY CALIBRATOR SET Wako Chemicals USA, Inc. | JIT |
| Jun 25, 2001 | K010334 | WAKO LIPID CALIBRATOR Wako Chemicals USA, Inc. | JIT |
| May 2, 2001 | K011126 | RAICHEM CREATININE URINE STANDARD Hemagen Diagnostics, Inc. | JIT |
| Apr 20, 2001 | K010314 | DIMENSION CTNI CALIBRATOR Dade Behring, Inc. | JIT |
| Mar 15, 2001 | K003501 | N PROTEIN STANDARD UY CALIBRATOR Dade Behring, Inc. | JIT |
| Mar 1, 2001 | K003411 | ELECSYS TESTOSTERONE CALSET II Roche Diagnostics Corp. | JIT |
| Feb 20, 2001 | K010208 | DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 Dade Behring, Inc. | JIT |
| Jan 26, 2001 | K003409 | ELECSYS FSH CALSET II Roche Diagnostics Corp. | JIT |
| Nov 30, 2000 | K003096 | FASTPACK CALIBRATORS Qualigen, Inc. | JIT |
| Nov 20, 2000 | K003098 | ACCESS ULTRASENSITIVE HGH CALIBRATORS Beckman Coulter, Inc. | JIT |
| May 4, 2000 | K000783 | DIRECT TIBC CALIBRATOR Reference Diagnostics, Inc. | JIT |
| Mar 1, 2000 | K994291 | DIMENSION SPECIAL PROTEIN CALIBRATOR Dade Behring, Inc. | JIT |
| Oct 4, 1999 | K993132 | GENZYME DIRECT AMYLASE VERIFIER Genzyme Corp. | JIT |
| Sep 24, 1999 | K992981 | ELECSYS ESTRADIOL CALSET II Roche Diagnostics Corp. | JIT |
| Jul 15, 1999 | K991705 | N PROTEIN STANDARD UY Dade Behring, Inc. | JIT |
| Jul 1, 1999 | K991176 | OPUS TROPONIN I CALIBRATOR Dade Behring, Inc. | JIT |
| Apr 16, 1999 | K990824 | REVISED C-REACTIVE PROTEIN CALIBRATOR Dade Behring, Inc. | JIT |
| Mar 22, 1999 | K990554 | DIMENSION SPECIAL PROTEIN CALIBRATOR Dade Behring, Inc. | JIT |
| Dec 14, 1998 | K984193 | DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR Dade Behring, Inc. | JIT |
| Nov 18, 1998 | K983850 | DIMENSION AHDL CALIBRATOR Dade Behring, Inc. | JIT |
| Nov 4, 1998 | K983722 | STRATUS CS TROPONIN I CALIBRATOR Dade Behring, Inc. | JIT |
| Nov 4, 1998 | K983693 | DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR Dade Behring, Inc. | JIT |
| Oct 27, 1998 | K983548 | FERRITIN CALIBRATOR Dade Behring, Inc. | JIT |
| Aug 18, 1998 | K981854 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR, Olympus Diagnostica GmbH | JIT |
| Aug 13, 1998 | K982292 | PREALBUMIN CALIBRATOR Dade Behring, Inc. | JIT |
| Apr 16, 1998 | K981100 | STRATUS CS TROP CALPAK Dade Behring, Inc. | JIT |
| Apr 16, 1998 | K981097 | STRATUS CS CKMB CALPAK Dade Behring, Inc. | JIT |
| Apr 15, 1998 | K981101 | STRATUS CS MYO CALPAK Dade Behring, Inc. | JIT |
| Oct 20, 1997 | K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR Dade Intl., Inc. | JIT |
| Sep 29, 1997 | K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Jun 16, 1997 | K964368 | ELECSYS CEA ASSAY Boehringer Mannheim Corp. | JIT |
| Mar 3, 1997 | K970336 | MMB CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Feb 18, 1997 | K970389 | THYROID CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
| Dec 3, 1996 | K963493 | FERRITIN CALIBRATOR Dade Chemistry Systems, Inc. | JIT |
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