The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Ebv Igm Test.
Device ID | K822734 |
510k Number | K822734 |
Device Name: | EBV IGM TEST |
Classification | Antiserum, Fluorescent, Epstein-barr Virus |
Applicant | GULL LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JRY |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-09 |
Decision Date | 1982-12-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840733102035 | K822734 | 000 |
00840733101946 | K822734 | 000 |