The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Quantitate Enzyme Verifier Set.
Device ID | K951293 |
510k Number | K951293 |
Device Name: | QUANTITATE ENZYME VERIFIER SET |
Classification | Enzyme Controls (assayed And Unassayed) |
Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Contact | Don W Hart |
Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Product Code | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-22 |
Decision Date | 1995-04-20 |