The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Crypto-cel If Test.
| Device ID | K955852 |
| 510k Number | K955852 |
| Device Name: | CRYPTO-CEL IF TEST |
| Classification | Cryptosporidium Spp. |
| Applicant | TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Contact | David M Lyerly, Ph.d. |
| Correspondent | David M Lyerly, Ph.d. TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1996-08-05 |
| Summary: | summary |