EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
FDA 510(k) clearance K852392 · decided 1985-10-22
Clearance details
- K-number
- K852392
- Device name
- EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-06-05
- Decision date
- 1985-10-22
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|
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| CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737) | Horiba Abx | 2007-06-12 |
| SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648) | Arkray, Inc. | 2006-01-31 |
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| WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332) | Wiener Laboratories Saic | 2002-07-03 |
Recalls involving this device
No recalls on record reference this clearance.