The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view-plus Immunochemical Fecal Occult Blood Test.
| Device ID | K173212 |
| 510k Number | K173212 |
| Device Name: | Instant-view-PLUS Immunochemical Fecal Occult Blood Test |
| Classification | Reagent, Occult Blood |
| Applicant | Alfa Scientific Designs, Inc. 13200 Gregg St Poway, CA 92064 |
| Contact | Wen Hua Fan |
| Correspondent | Wen Hua Fan Alfa Scientific Designs, Inc. 13200 Gregg St Poway, CA 92064 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10023513132140 | K173212 | 000 |
| 10023513132157 | K173212 | 000 |