FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANA/LITE-HEP-2 TEST SYSTEM
K Number: K852231
·
Decision Jul 10, 1985
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
12
Review Days
49
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Basic Information
- Device Name
- ANA/LITE-HEP-2 TEST SYSTEM
- K Number
- K852231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Products Industries
- Date Received
- May 22, 1985
- Decision Date
- July 10, 1985
- Product Code
- LJM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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Other Clearances by Immuno-Products Industries
| K Number | Device Name | ||
|---|---|---|---|
| K853122 | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | Sep 19, 1985 | Substantially Equivalent |
| K852230 | ANA/LITE-RL 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 |