The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Antibody To Varicella-zoster Virus.
| Device ID | K800787 |
| 510k Number | K800787 |
| Device Name: | ANTIBODY TO VARICELLA-ZOSTER VIRUS |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-08 |
| Decision Date | 1980-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5229028011 | K800787 | 000 |
| G5229028001 | K800787 | 000 |