VIRGO(R) MICROWELL ALT ASSAY
FDA 510(k) clearance K884784 · decided 1988-12-29
Clearance details
- K-number
- K884784
- Device name
- VIRGO(R) MICROWELL ALT ASSAY
- Applicant
- Electro-Nucleonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-15
- Decision date
- 1988-12-29
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- CKD
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834) | Cholestech Corp. | 1999-09-09 |
| ORTHO ALT MICROWELL TEST SYSTEM (K941192) | Ortho Diagnostic Systems, Inc. | 1995-05-16 |
| COBAS READY ALT REAGENT (K896237) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387) | Tech-Co, Inc. | 1988-10-13 |
| REFLOTRON(R) ALT (GPT) (K864082) | Boehringer Mannheim Corp. | 1986-12-04 |
| SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485) | Sterling Diagnostics, Inc. | 1986-04-03 |
| SGPT REAGENT SET (K844283) | Livonia Diagnostics, Inc. | 1984-11-27 |
| SGPT REAGENT SET (K841059) | Medical Specialties, Inc. | 1984-05-01 |
| SGPT REAGENT SET (K821207) | Omega Medical Electronics | 1982-07-14 |
| SGPT REAGENT SET (K820491) | Anco Medical Reagents & Assoc. | 1982-03-11 |
Recalls involving this device
No recalls on record reference this clearance.