The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Specialty Assayed Control-1.
Device ID | K941737 |
510k Number | K941737 |
Device Name: | SPECIALTY ASSAYED CONTROL-1 |
Classification | Plasma, Control, Normal |
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 | GIZ |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-07 |
Decision Date | 1994-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855360006243 | K941737 | 000 |