ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
FDA 510(k) clearance K950803 · decided 1995-09-21
Clearance details
- K-number
- K950803
- Device name
- ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-21
- Decision date
- 1995-09-21
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- JJT
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences recall (Z-1139-03) | PerkinElmer Life Sciences Inc | 2003-08-20 |
| Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences In recall (Z-0898-03) | PerkinElmer LIfe Sciences Inc | 2003-05-29 |