FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
K Number: K901972
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
2
Review Days
127
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Basic Information
- Device Name
- ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
- K Number
- K901972
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Novo Nordisk Diagnostics, Ltd.
- Date Received
- May 1, 1990
- Decision Date
- September 5, 1990
- 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 Novo Nordisk Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K911430 | IDEIA(TM) CHLAMYDIA, MODIFICATION | Aug 7, 1991 | Substantially Equivalent |