The following data is part of a premarket notification filed by Canberra Industries, Inc. with the FDA for Matrix(tm)-96.
Device ID | K896202 |
510k Number | K896202 |
Device Name: | MATRIX(TM)-96 |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | CANBERRA INDUSTRIES, INC. ONE STATE ST. Meriden, CT 06450 |
Contact | James T Cerreto |
Correspondent | James T Cerreto CANBERRA INDUSTRIES, INC. ONE STATE ST. Meriden, CT 06450 |
Product Code | JJJ |
CFR Regulation Number | 862.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-26 |
Decision Date | 1990-01-02 |