The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Two-step Acid Fast Bacteria Stain.
| Device ID | K851494 |
| 510k Number | K851494 |
| Device Name: | TWO-STEP ACID FAST BACTERIA STAIN |
| Classification | Stains, Microbiologic |
| Applicant | ACCRA LABORATORIES, INC. P.O. BOX 518 Bridgeport, NJ 08014 |
| Contact | Robert C Thatcher |
| Correspondent | Robert C Thatcher ACCRA LABORATORIES, INC. P.O. BOX 518 Bridgeport, NJ 08014 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-04-29 |