FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU
K Number: K821019
·
Decision Apr 26, 1982
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
4
Applicant Total
14
Review Days
14
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Basic Information
- Device Name
- PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU
- K Number
- K821019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Research Corp.
- Date Received
- April 12, 1982
- Decision Date
- April 26, 1982
- Product Code
- LEB
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| LEB | Mounting Media | FDA class 1 | Pathology |
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Other Clearances by Microbiological Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Apr 26, 1989 | Substantially Equivalent |
| 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 |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Jan 29, 1981 | Substantially Equivalent |
| K803133 | RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL | Jan 29, 1981 | Substantially Equivalent |