FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPS IGG ELISA TESTY
K Number: K971857
·
Decision Nov 4, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
57
Review Days
168
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Basic Information
- Device Name
- MUMPS IGG ELISA TESTY
- K Number
- K971857
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gull Laboratories, Inc.
- Date Received
- May 20, 1997
- Decision Date
- November 4, 1997
- Product Code
- LJY
- 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 |
|---|---|---|---|
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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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 |
| 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 |
| K941624 | RUBELLA IGG ELISA TEST | Aug 4, 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 |