The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Dipstick Salmonella.
| Device ID | K910438 |
| 510k Number | K910438 |
| Device Name: | DIPSTICK SALMONELLA |
| Classification | Antisera, All Groups, Salmonella Spp. |
| Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Contact | Raymond L Miller |
| Correspondent | Raymond L Miller AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
| Product Code | GRM |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-09-13 |