FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MRI NEO-TRYP TRYPSIN RIA
K Number: K883011
·
Decision Apr 26, 1989
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
6
Applicant Total
14
Review Days
281
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Basic Information
- Device Name
- MRI NEO-TRYP TRYPSIN RIA
- K Number
- K883011
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1725
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Research Corp.
- Date Received
- July 19, 1988
- Decision Date
- April 26, 1989
- Product Code
- JNO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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RIA KIT FOR TRYPSIN
FDA 510(k)
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Other Clearances by Microbiological Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K861121 | THE GOLDEN QUAD TEST (EBV) | Feb 2, 1987 | Substantially Equivalent |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Feb 2, 1987 | Substantially Equivalent |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Feb 2, 1987 | Substantially Equivalent |
| K861120 | THE GOLDEN QUAD TEST (HSV) | Feb 2, 1987 | Substantially Equivalent |
| K860450 | THE CMV-IGM TEST | May 13, 1986 | Substantially Equivalent |
| K843138 | CMV TEST | Jan 29, 1985 | Substantially Equivalent |
| K821018 | ANTIHUMAN IGG GLOBULIN FITC LABELED | Apr 29, 1982 | Substantially Equivalent |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Apr 26, 1982 | Substantially Equivalent |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Jan 29, 1981 | Substantially Equivalent |
| K803133 | RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL | Jan 29, 1981 | Substantially Equivalent |