The following data is part of a premarket notification filed by Fuller Laboratories, Inc. with the FDA for Fuller Laboratories Mycoplasm Pneumonia Ifa-igg Test.
| Device ID | K931557 |
| 510k Number | K931557 |
| Device Name: | FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST |
| Classification | Antisera, Fluorescent, All, Mycoplasma Spp. |
| Applicant | FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton, CA 92631 |
| Contact | Lee Fuller |
| Correspondent | Lee Fuller FULLER LABORATORIES, INC. 2478 E. FENDER, UNIT 1 Fullerton, CA 92631 |
| Product Code | GRZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-03-11 |