The following data is part of a premarket notification filed by Gbf Medical Group with the FDA for Drug, Insurance, Urinalysis, Blood/urine Test Kits.
| Device ID | K931474 |
| 510k Number | K931474 |
| Device Name: | DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS |
| Classification | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
| Applicant | GBF MEDICAL GROUP 410-J GALLIMORE DAIRY RD. Greensboro, NC 27409 |
| Contact | Danny Bowman |
| Correspondent | Danny Bowman GBF MEDICAL GROUP 410-J GALLIMORE DAIRY RD. Greensboro, NC 27409 |
| Product Code | KDW |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1994-05-10 |