FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
K Number: K853122
·
Decision Sep 19, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
12
Review Days
56
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Basic Information
- Device Name
- IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED
- K Number
- K853122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Products Industries
- Date Received
- July 25, 1985
- Decision Date
- September 19, 1985
- Product Code
- GMS
- 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 |
|---|---|---|---|
| GMS | Anti-Human Globulin, Fta-Abs Test | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMS), ordered by most recent decision date.
FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
FDA 510(k)
FDA Class 2
·Microbiology
FTA-ABS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Immuno-Products Industries
| K Number | Device Name | ||
|---|---|---|---|
| K852230 | ANA/LITE-RL TEST SYSTEM | Jul 10, 1985 | Substantially Equivalent |
| K852231 | ANA/LITE-HEP-2 TEST SYSTEM | Jul 10, 1985 | Substantially Equivalent |
| K843613 | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | Oct 31, 1984 | Substantially Equivalent |
| K831054 | ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB | Apr 27, 1983 | Substantially Equivalent |
| K830652 | ANTI N DNA-HCP | Mar 24, 1983 | Substantially Equivalent |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | Jun 10, 1982 | Substantially Equivalent |
| K810984 | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST | May 1, 1981 | Substantially Equivalent |
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | May 1, 1981 | Substantially Equivalent |
| K810985 | ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT | May 1, 1981 | Substantially Equivalent |
| K810982 | ANTITHYROID ANTIBODY IMMUNOFLUORESCENT | May 1, 1981 | Substantially Equivalent |