The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Prothrombin Time Test.
Device ID | K872537 |
510k Number | K872537 |
Device Name: | PROTHROMBIN TIME TEST |
Classification | Test, Time, Prothrombin |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | Debra Hofmeister |
Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | GJS |
CFR Regulation Number | 864.7750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-25 |
Decision Date | 1987-08-27 |