The following data is part of a premarket notification filed by Whatman Specialty Products, Inc. with the FDA for Whatman Body Fluid Collection Paper:whatman Bfc180.
Device ID | K932661 |
510k Number | K932661 |
Device Name: | WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 |
Classification | Newborn Screening Specimen Collection Paper |
Applicant | WHATMAN SPECIALTY PRODUCTS, INC. 6 JUST RD. Fairfield, NJ 07004 |
Contact | Richard J Coppola |
Correspondent | Richard J Coppola WHATMAN SPECIALTY PRODUCTS, INC. 6 JUST RD. Fairfield, NJ 07004 |
Product Code | PJC |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-02 |
Decision Date | 1996-04-17 |