FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLA IGG ELISA TEST
K Number: K941624
·
Decision Aug 4, 1995
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
57
Review Days
487
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Basic Information
- Device Name
- RUBELLA IGG ELISA TEST
- K Number
- K941624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gull Laboratories, Inc.
- Date Received
- April 4, 1994
- Decision Date
- August 4, 1995
- 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 Gull Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983541 | HSV 1+2 IGG ELISA TEST | Feb 26, 1999 | Substantially Equivalent |
| K971857 | MUMPS IGG ELISA TESTY | Nov 4, 1997 | Substantially Equivalent |
| K962343 | TOXO IGG ELISA TEST | Mar 24, 1997 | Substantially Equivalent |
| K935730 | EBNA IGG ELISA TEST | Sep 19, 1995 | Substantially Equivalent |
| K940093 | EBV-EA(D) IGG ELISA TEST | Sep 15, 1995 | Substantially Equivalent |
| K941046 | VZV IGG ELISA TEST | Aug 24, 1995 | Substantially Equivalent |
| K941198 | EBV LGG ELISA TEST | Aug 23, 1995 | Substantially Equivalent |
| K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | Aug 15, 1995 | Substantially Equivalent |
| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Oct 5, 1992 | Substantially Equivalent |
| K922759 | HSV-2 IGM ELISA TEST--MODIFICATION | Oct 5, 1992 | Substantially Equivalent |