The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Fecal Occult Blood Rapid Test.
| Device ID | K021423 |
| 510k Number | K021423 |
| Device Name: | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST |
| Classification | Reagent, Occult Blood |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-03 |
| Decision Date | 2002-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613202059 | K021423 | 000 |
| 30014613202042 | K021423 | 000 |
| 30014613202011 | K021423 | 000 |
| 30014613201960 | K021423 | 000 |
| 30014613201946 | K021423 | 000 |