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 |