FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRGO(R) MICROWELL ALT ASSAY
K Number: K884784
·
Decision Dec 29, 1988
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
9
Review Days
44
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Basic Information
- Device Name
- VIRGO(R) MICROWELL ALT ASSAY
- K Number
- K884784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Electro-Nucleonics, Inc.
- Date Received
- November 15, 1988
- Decision Date
- December 29, 1988
- Product Code
- CKD
- 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 |
|---|---|---|---|
| CKD | Hydrazone Colorimetry, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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REFLOTRON(R) ALT (GPT)
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Other Clearances by Electro-Nucleonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893718 | DELTATEST (R) LIPASE II | Sep 28, 1989 | Substantially Equivalent |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Apr 28, 1989 | Substantially Equivalent |
| K883281 | VIRGO HSV-2 IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883427 | VIRGO(R) VZV-IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883282 | VIRGO HSV-1 IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883102 | VIRGO (R) CMV-IGG ELISA | Feb 8, 1989 | Substantially Equivalent |
| K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT | Sep 9, 1988 | Substantially Equivalent |
| K883206 | LACTATE DEHYDROGENASE LDH | Sep 9, 1988 | Substantially Equivalent |