The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Alkaline Phosphatase Reagent, Cholinesterase Reagent, Gamma-glutamyl Transferase Reagent, Lactate Dehyd.
| Device ID | K971333 |
| 510k Number | K971333 |
| Device Name: | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JIX |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CJE |
| Subsequent Product Code | DIH |
| Subsequent Product Code | JPZ |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590625689 | K971333 | 000 |
| 15099590575168 | K971333 | 000 |
| 15099590233044 | K971333 | 000 |