The following data is part of a premarket notification filed by Proteins Intl., Inc. with the FDA for 16 X 125 Mm Test Tube, Catalog #01-211.
Device ID | K930375 |
510k Number | K930375 |
Device Name: | 16 X 125 MM TEST TUBE, CATALOG #01-211 |
Classification | Cells, Animal And Human, Cultured |
Applicant | PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
Contact | Victoria E Walley |
Correspondent | Victoria E Walley PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
Product Code | KIR |
CFR Regulation Number | 864.2280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1993-03-23 |