The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Beckman Synchron Lactate Reagent.
| Device ID | K934271 |
| 510k Number | K934271 |
| Device Name: | BECKMAN SYNCHRON LACTATE REAGENT |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1993-11-09 |