The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fluorescein Conjugated Anti-chlamydia Mono Anti.
| Device ID | K883352 |
| 510k Number | K883352 |
| Device Name: | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Contact | Leif Olsen |
| Correspondent | Leif Olsen WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville, MD 21793 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-10-06 |