The following data is part of a premarket notification filed by The Dow Chemical Co. with the FDA for Colorimetric Determination (ldh).
| Device ID | K760009 |
| 510k Number | K760009 |
| Device Name: | COLORIMETRIC DETERMINATION (LDH) |
| Classification | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Applicant | THE DOW CHEMICAL CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CFH |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-10 |
| Decision Date | 1976-07-20 |