The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Helena Colocare.
| Device ID | K882799 |
| 510k Number | K882799 |
| Device Name: | HELENA COLOCARE |
| Classification | Reagent, Occult Blood |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Eric Petersen |
| Correspondent | Eric Petersen HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-06 |
| Decision Date | 1988-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52556560 | K882799 | 000 |
| M52556510 | K882799 | 000 |
| M52556500 | K882799 | 000 |
| M5255521380 | K882799 | 000 |
| M5255515470 | K882799 | 000 |