FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
K Number: K931374
·
Decision Jun 15, 1993
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
- K Number
- K931374
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microprobe Corp.
- Date Received
- March 18, 1993
- Decision Date
- June 15, 1993
- Product Code
- MLA
- 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 |
|---|---|---|---|
| MLA | Dna Probe, Yeast | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MLA), ordered by most recent decision date.
View allOther Clearances by Microprobe Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931151 | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA | Jun 18, 1993 | Substantially Equivalent |
| K923133 | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | Sep 25, 1992 | Substantially Equivalent |
| K922457 | AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA | Sep 25, 1992 | Substantially Equivalent |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | Jul 30, 1992 | Substantially Equivalent |
| K923268 | AFFIRM PROCESSOR | Jul 30, 1992 | Substantially Equivalent |