The following data is part of a premarket notification filed by Laboratory Diagnostics Co., Inc. with the FDA for Quick Cult Slide Test Fecal Occult Blood.
| Device ID | K761232 |
| 510k Number | K761232 |
| Device Name: | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD |
| Classification | Reagent, Occult Blood |
| Applicant | LABORATORY DIAGNOSTICS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-10 |
| Decision Date | 1976-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B224SB211 | K761232 | 000 |
| B224SB201 | K761232 | 000 |
| B224SB191 | K761232 | 000 |