The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Hemoccult Sensitive Test.
| Device ID | K880499 |
| 510k Number | K880499 |
| Device Name: | HEMOCCULT SENSITIVE TEST |
| Classification | Reagent, Occult Blood |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. San Jose, CA 95134 -1622 |
| Contact | Ronald Schoengold |
| Correspondent | Ronald Schoengold SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. San Jose, CA 95134 -1622 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590226794 | K880499 | 000 |
| 15099590226770 | K880499 | 000 |
| 15099590224776 | K880499 | 000 |
| 15099590224707 | K880499 | 000 |