The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Hemoccult Wipe Test.
| Device ID | K862849 |
| 510k Number | K862849 |
| Device Name: | HEMOCCULT WIPE TEST |
| Classification | Reagent, Occult Blood |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 485 POTRERO AVE. P.O. BOX 61947 Sunnyvale, CA 94086 |
| Contact | Ronald J Schoengold |
| Correspondent | Ronald J Schoengold SMITH KLINE DIAGNOSTICS, INC. 485 POTRERO AVE. P.O. BOX 61947 Sunnyvale, CA 94086 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-12-09 |