FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
K Number: K904501
·
Decision Feb 26, 1991
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
12
Applicant Total
57
Review Days
147
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Basic Information
- Device Name
- MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
- K Number
- K904501
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Diagnostic Technologies, Inc.
- Date Received
- October 2, 1990
- Decision Date
- February 26, 1991
- 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
FDA 510(k)
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|---|---|---|---|
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| K963106 | CHROMOLIZE PAI-1 KIT | Nov 18, 1996 | Substantially Equivalent |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Aug 14, 1996 | Substantially Equivalent |
| K962489 | CHROMOLIZE TPA ASSAY KIT | Jul 31, 1996 | Substantially Equivalent |
| K960438 | TINTELIZE PAI-1 KIT | Jun 5, 1996 | Substantially Equivalent |
| K961724 | U-DOA CONTROLS | Jun 3, 1996 | Substantially Equivalent |
| K961370 | LA POSITIVE CONTROL PLASMA | May 24, 1996 | Substantially Equivalent |
| K955115 | VENOM TIEM REAGENT | Apr 3, 1996 | Substantially Equivalent |
| K955738 | BIOCLOT PROTEIN S | Feb 29, 1996 | Substantially Equivalent |