The following data is part of a premarket notification filed by Cambridge Chemical Products, Inc. with the FDA for Fecal Occult Slide Test Kit.
| Device ID | K830223 |
| 510k Number | K830223 |
| Device Name: | FECAL OCCULT SLIDE TEST KIT |
| Classification | Reagent, Occult Blood |
| Applicant | CAMBRIDGE CHEMICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414538396 | K830223 | 000 |
| 00630414538389 | K830223 | 000 |