The following data is part of a premarket notification filed by Diagnology Ltd. with the FDA for Pockit Hsv 2 Rapid Test.
| Device ID | K983886 |
| 510k Number | K983886 |
| Device Name: | POCKIT HSV 2 RAPID TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | DIAGNOLOGY LTD. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff DIAGNOLOGY LTD. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951056439 | K983886 | 000 |