510(k) K931474
K931474 is an FDA 510(k) premarket notification submitted by Gbf Medical Group for the device "DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS". The FDA issued a decision of Substantially Equivalent (kit) on May 10, 1994. The device falls under product code KDW (Container, Specimen Mailer And Storage, Temperature Controlled, Sterile), a Class I device regulated under 21 CFR 864.3250.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- May 10, 1994
- Date Received
- March 24, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- PA
- Submission Type