The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-skin Antibody Test(monkey/guin Pig Esoph Sec).
| Device ID | K891099 |
| 510k Number | K891099 |
| Device Name: | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Russell Nisengard |
| Correspondent | Russell Nisengard IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714003554 | K891099 | 000 |