FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNODOT RUBELLA TEST
K Number: K885082
·
Decision Feb 2, 1989
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
23
Review Days
55
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Basic Information
- Device Name
- IMMUNODOT RUBELLA TEST
- K Number
- K885082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- General Biometrics, Inc.
- Date Received
- December 9, 1988
- Decision Date
- February 2, 1989
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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Other Clearances by General Biometrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | Dec 1, 1992 | Substantially Equivalent |
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | Aug 20, 1992 | Substantially Equivalent |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | Aug 20, 1992 | Substantially Equivalent |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | Apr 8, 1992 | Substantially Equivalent |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | Dec 30, 1991 | Substantially Equivalent |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | Dec 20, 1991 | Substantially Equivalent |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | Dec 9, 1991 | Substantially Equivalent |
| K911848 | IMMUNOWELL RNP/SM ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | May 7, 1991 | Substantially Equivalent |