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 |