The following data is part of a premarket notification filed by Allied Fisher Scientific with the FDA for Fisher Diagnostic Latest Aso Test Kit.
| Device ID | K852701 |
| 510k Number | K852701 |
| Device Name: | FISHER DIAGNOSTIC LATEST ASO TEST KIT |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | ALLIED FISHER SCIENTIFIC 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer ALLIED FISHER SCIENTIFIC 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-26 |
| Decision Date | 1985-07-19 |