The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Test Kit For Mycoplasma Pneumoniae-g Antibody.
| Device ID | K861716 |
| 510k Number | K861716 |
| Device Name: | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY |
| Classification | Antisera, Fluorescent, All, Mycoplasma Spp. |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Louise M Harris |
| Correspondent | Louise M Harris WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | GRZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-08-08 |