FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K Number: K984153
·
Decision Jan 11, 1999
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
12
Applicant Total
135
Review Days
53
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Basic Information
- Device Name
- THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
- K Number
- K984153
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- November 19, 1998
- Decision Date
- January 11, 1999
- 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.
MYCOPLASMA IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
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MYCOPLASMA IGG ELISA TEST SYSTEM
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MYCOPLASMA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
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IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
FDA 510(k)
FDA Class 1
·Microbiology
IMMUNOCARD MYCOPLASMA
FDA 510(k)
FDA Class 1
·Microbiology
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