The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Scale Set Solutions/405nm Cat#1480-650nm Cat#1479.
| Device ID | K924915 |
| 510k Number | K924915 |
| Device Name: | SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-29 |
| Decision Date | 1992-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52514790 | K924915 | 000 |