ISOMUNE-CK
FDA 510(k) clearance K810905 · decided 1981-04-14
Clearance details
- K-number
- K810905
- Device name
- ISOMUNE-CK
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-03
- Decision date
- 1981-04-14
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- JHW
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 (K023744) | Wiener Laboratories Saic | 2003-01-03 |
| ROCHE DIAGNOSTICS CK-MB (K003158) | Roche Diagnostics Corp. | 2000-12-18 |
| ELECSYS CK-MB (K961501) | Boehringer Mannheim Corp. | 1996-06-11 |
| CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186) | Miles, Inc. | 1995-03-13 |
| LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (K944325) | Princeton BioMeditech Corp. | 1995-02-22 |
| CREATINE KINASE MB DETERMINATION (UV) (K942958) | Biochemical Trade, Inc. | 1994-11-21 |
| AXSYM CK-MB (K935924) | Abbott Laboratories | 1994-06-21 |
| CARDIO REP CK ISOENZYME KIT - 3310 (K931050) | Helena Laboratories | 1993-04-20 |
| STAMBI-CK (K913349) | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CEA-ROCHE TEST KIT (P800063/S004) | Hoffmann-La Roche, Inc. | 1983-10-18 |
| CEA-ROCHE TEST KIT (P800063/S003) | Hoffmann-La Roche, Inc. | 1982-10-21 |
| CEA-ROCHE TEST KIT (P800063/S002) | Hoffmann-La Roche, Inc. | 1982-09-16 |
| CEA-ROCHE TEST KIT (P800063/S001) | Hoffmann-La Roche, Inc. | 1982-03-03 |