510(k) K853141
K853141 is an FDA 510(k) premarket notification submitted by Medtech Products, Inc. for the device "ACCESS DIGIWIPE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Medtech Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1985
- Date Received
- July 24, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Occult Blood
- Device Class
- Class II
- Regulation Number
- 864.6550
- Review Panel
- HE
- Submission Type