FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARDX MITOCHONDRIA EIA TEST SYSTEM
K Number: K950110
·
Decision May 15, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
26
Review Days
124
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Basic Information
- Device Name
- MARDX MITOCHONDRIA EIA TEST SYSTEM
- K Number
- K950110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- January 11, 1995
- Decision Date
- May 15, 1995
- Product Code
- LJM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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Other Clearances by Hogan & Hartson
| K Number | Device Name | ||
|---|---|---|---|
| K974168 | COOPERSURGICAL INFRARED COAGULATOR | Jan 23, 1998 | Substantially Equivalent |
| K973849 | BIOABSORBABLE BANKART TACK | Jan 6, 1998 | Substantially Equivalent |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Nov 20, 1997 | Substantially Equivalent |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | May 23, 1996 | Substantially Equivalent |
| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Feb 16, 1996 | Substantially Equivalent |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K941566 | COMPUSPEAK | Jun 30, 1995 | Substantially Equivalent |