The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Gullsorb Igg Inactivation Reagent.
| Device ID | K875254 |
| 510k Number | K875254 |
| Device Name: | GULLSORB IGG INACTIVATION REAGENT |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Rachford, Phd |
| Correspondent | Rachford, Phd GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101304 | K875254 | 000 |