The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Isolab's Galactose-1-phosphate Uridyl Tranferase Test Kits 800, 4000 Sample.
| Device ID | K950803 |
| 510k Number | K950803 |
| Device Name: | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Janet Perkins |
| Correspondent | Janet Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-21 |
| Decision Date | 1995-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147001279 | K950803 | 000 |
| 06438147001262 | K950803 | 000 |