510(k) K931241
K931241 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "FAST'N'FLAMMATORY KIT". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code GIA (Test, Leukocyte Peroxidase), a Class I device regulated under 21 CFR 864.7675. Techlab, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1994
- Date Received
- March 11, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Leukocyte Peroxidase
- Device Class
- Class I
- Regulation Number
- 864.7675
- Review Panel
- PA
- Submission Type