The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Lactate Dehydrogenase Reagent Set.
| Device ID | K961431 |
| 510k Number | K961431 |
| Device Name: | LACTATE DEHYDROGENASE REAGENT SET |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439020970 | K961431 | 000 |
| 00817439020963 | K961431 | 000 |