FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
K Number: K922457
·
Decision Sep 25, 1992
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
6
Review Days
122
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Basic Information
- Device Name
- AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
- K Number
- K922457
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Microprobe Corp.
- Date Received
- May 26, 1992
- Decision Date
- September 25, 1992
- Product Code
- MJK
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJK | Dna Probe, Trichomonas Vaginalis | FDA class 1 | Microbiology |
Other Clearances by Microprobe Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931151 | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA | Jun 18, 1993 | Substantially Equivalent |
| K931374 | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST | Jun 15, 1993 | Substantially Equivalent |
| K923133 | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | Sep 25, 1992 | Substantially Equivalent |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | Jul 30, 1992 | Substantially Equivalent |
| K923268 | AFFIRM PROCESSOR | Jul 30, 1992 | Substantially Equivalent |