The following data is part of a premarket notification filed by Devetec, Inc. with the FDA for Price's Acid-fast Stain.
| Device ID | K870988 |
| 510k Number | K870988 |
| Device Name: | PRICE'S ACID-FAST STAIN |
| Classification | Stains, Microbiologic |
| Applicant | DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Contact | Price, Phd |
| Correspondent | Price, Phd DEVETEC, INC. P.O. BOX 10275 Bradenton, FL 34282 -0275 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-11 |
| Decision Date | 1987-03-30 |