The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Cryptosporidium Test.
| Device ID | K980354 |
| 510k Number | K980354 |
| Device Name: | CRYPTOSPORIDIUM 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 | 1998-01-29 |
| Decision Date | 1998-05-18 |
| Summary: | summary |