FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPLASMA IGG ELISA TEST SYSTEM
K Number: K971393
·
Decision Jul 14, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
12
Applicant Total
14
Review Days
96
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Basic Information
- Device Name
- MYCOPLASMA IGG ELISA TEST SYSTEM
- K Number
- K971393
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunoprobe, Inc.
- Date Received
- April 9, 1997
- Decision Date
- July 14, 1997
- Product Code
- LJZ
- 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 |
|---|---|---|---|
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJZ), ordered by most recent decision date.
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
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IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
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IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
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FDA Class 1
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IMMUNOCARD MYCOPLASMA
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Immunoprobe, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | Dec 22, 1997 | Substantially Equivalent |
| K961765 | MPO ELISA TEST SYSTEM | Aug 19, 1996 | Substantially Equivalent |
| K961764 | PR-3 ELISA TEST SYSTEM | Aug 19, 1996 | Substantially Equivalent |
| K951549 | EBNA IGG EIA TEST SYSTEM | Apr 29, 1996 | Substantially Equivalent |
| K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K952523 | CARDIOLIPIN IGG EIA TEST KIT | Feb 9, 1996 | Substantially Equivalent |
| K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K951364 | MICROSOMAL EIA TEST KIT | Nov 20, 1995 | Substantially Equivalent |
| K951362 | THYROGLOBULIN EIA TEST KIT | Nov 20, 1995 | Substantially Equivalent |
| K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM | Oct 13, 1995 | Substantially Equivalent |