510(k) K922457
K922457 is an FDA 510(k) premarket notification submitted by Microprobe Corp. for the device "AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code MJK (Dna Probe, Trichomonas Vaginalis), a Class I device regulated under 21 CFR 866.2660. Microprobe Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1992
- Date Received
- May 26, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna Probe, Trichomonas Vaginalis
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type