The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Protofluor Z.
| Device ID | K893038 |
| 510k Number | K893038 |
| Device Name: | PROTOFLUOR Z |
| Classification | Fluorometric Measurement, Porphyrins |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JKJ |
| CFR Regulation Number | 862.1595 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52520060000 | K893038 | 000 |
| M52520050020 | K893038 | 000 |
| M52520050000 | K893038 | 000 |