510(k) K812603
K812603 is an FDA 510(k) premarket notification submitted by Marketing Consultants of America for the device "TANARAMA". The FDA issued a decision of Substantially Equivalent on November 20, 1981. The device falls under product code GGG (Guaiac Reagent), a Class II device regulated under 21 CFR 864.6550. Marketing Consultants of America has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1981
- Date Received
- September 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guaiac Reagent
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type