The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Ldh-l Reagent Set.
| Device ID | K973589 |
| 510k Number | K973589 |
| Device Name: | LIQUID LDH-L 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 | 1997-09-22 |
| Decision Date | 1997-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014771 | K973589 | 000 |
| 00811727016201 | K973589 | 000 |
| 00817439020987 | K973589 | 000 |
| 00817439021007 | K973589 | 000 |
| 00811727011732 | K973589 | 000 |
| 00811727011749 | K973589 | 000 |
| 00811727011756 | K973589 | 000 |
| 00811727012739 | K973589 | 000 |
| 00811727013064 | K973589 | 000 |
| 00811727013620 | K973589 | 000 |
| 00811727014313 | K973589 | 000 |
| 00811727014320 | K973589 | 000 |
| 00811727014337 | K973589 | 000 |
| 00811727014344 | K973589 | 000 |
| 00811727015907 | K973589 | 000 |