The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep(tm) Spe Plus-16 (ponceau S) And (amido).
| Device ID | K901463 |
| 510k Number | K901463 |
| Device Name: | REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) |
| Classification | Densitometeric, Protein Fractionation |
| 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 | JQJ |
| CFR Regulation Number | 862.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-28 |
| Decision Date | 1990-06-12 |