The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Rabbit Plasma Fibrinogen Supplement Sr 122.
Device ID | K870945 |
510k Number | K870945 |
Device Name: | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 |
Classification | Plasma, Coagulase, Human, Horse And Rabbit |
Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Contact | Ruth Kemp |
Correspondent | Ruth Kemp OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Product Code | JTL |
CFR Regulation Number | 866.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-09 |
Decision Date | 1987-06-10 |