FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIVID CHLAMYDIA(TM)
K Number: K872148
·
Decision Aug 19, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
20
Review Days
76
Basic Information
- Device Name
- VIVID CHLAMYDIA(TM)
- K Number
- K872148
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- SERAGEN DIAGNOSTICS, INC.
- Date Received
- June 4, 1987
- Decision Date
- August 19, 1987
- Product Code
- LJC
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
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Other Clearances by SERAGEN DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | Jul 23, 1985 | Substantially Equivalent |
| K852260 | QUICK-CHEM CALIBRATION SET | Jul 22, 1985 | Substantially Equivalent |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | Jun 25, 1985 | Substantially Equivalent |
| K851521 | LD-1(IMMUNO) SEPARATION SET | May 10, 1985 | Substantially Equivalent |
| K850209 | QUICK-LYTE | Feb 27, 1985 | Substantially Equivalent |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | Feb 4, 1985 | Substantially Equivalent |
| K842563 | SERATEST DNA DETERMINATION | Oct 25, 1984 | Substantially Equivalent |
| K841504 | QUICK-COUNT PLUS 2 | Jun 11, 1984 | Substantially Equivalent |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Apr 13, 1984 | Substantially Equivalent |
| K840863 | SERATEST RF LATEX DETERMINATION | Apr 4, 1984 | Substantially Equivalent |