510(k) K855188
- Device
- CPK (UV) REAGENT KIT
- Applicant
- TECHNOSTICS INTL.
- 510(k) number
- K855188
- Product code
- JHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-05
- Date received
- 1985-12-26
- 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
- SUSAN RENEHAN
- Address
- P.O. Box 94090 Washington MI US 48094 48094
FDA Registration Numbers#
- 1319809
- 2250051
- 1219913
- 9610126
- 3006198300
- 2432235
- 1319681
- 3003795116
- 2517506
- 9681753
- 9610529
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 |
| K883223 | CHECK-MM | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 |
Legacy Summary#
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FDA Review#
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