510(k) K883223
- Device
- CHECK-MM
- Applicant
- INTL. IMMUNOASSAY LABORATORIES, INC.
- 510(k) number
- K883223
- Product code
- JHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-30
- Date received
- 1988-07-29
- Regulation
- 862.1215
- Classification name
- Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHAH, PH.D.
- Address
- 1900 Wyatt Dr., #11 Santa Clara CA US 95054 95054
FDA Registration Numbers#
- 9610529
- 2517506
- 2432235
- 9681753
- 2250051
- 9610126
- 3006198300
- 3003795116
- 1319809
- 1219913
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| K102706 | CKMB UDR ASSAY | SENTINEL CH. SpA | 2011-08-19 |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 |
| K062128 | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | Dade Behring, Inc. | 2006-08-21 |
| K990439 | CARESIDE CK | Careside, Inc. | 1999-04-19 |
| K990434 | CARESIDE CKMB | Careside, Inc. | 1999-04-19 |
| K981495 | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | Diagnostic Products Corp. | 1998-06-10 |
| K962126 | ACS CKMB II IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT | Dade Intl., Inc. | 1995-07-17 |
| K945083 | ACCESS CK-MB REAGENTS | Bio-Rad Laboratories, Inc. | 1994-11-21 |
| K943024 | KINASE ISOENZYME | Dupont Medical Products | 1994-08-02 |
| K941584 | CREATINE KINASE METHOD | Dupont Medical Products | 1994-07-06 |
| K903025 | ROCHE ISOMUNE- CK | Roche Diagnostic Systems, Inc. | 1990-08-09 |
| K900806 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1990-03-23 |
| K872029 | UNI-FAST CREATINE KINASE TEST (CK) | Sclavo, Inc. | 1987-06-17 |
Legacy Summary#
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FDA Review#
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