The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Easy-test Lactic Acid (la).
| Device ID | K880787 |
| 510k Number | K880787 |
| Device Name: | EASY-TEST LACTIC ACID (LA) |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Raymond L Miller |
| Correspondent | Raymond L Miller DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-03-15 |