The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Rapid Glutamic Acid Decarboxylase (gdc) Microtube.
| Device ID | K860301 |
| 510k Number | K860301 |
| Device Name: | RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. P.O. BOX 1328 Stone Mountain, GA 30086 |
| Contact | L. C Scarborough |
| Correspondent | L. C Scarborough 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 | 1986-01-28 |
| Decision Date | 1986-02-06 |