The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Neis Nzy.
Device ID | K863216 |
510k Number | K863216 |
Device Name: | NEIS NZY |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
Contact | Scarborough, Jr |
Correspondent | Scarborough, Jr CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-20 |
Decision Date | 1986-09-15 |