FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOTECH HSV IGG ENZYME IMMUNOASSAY
K Number: K862838
·
Decision Dec 9, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
10
Review Days
137
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Basic Information
- Device Name
- CYTOTECH HSV IGG ENZYME IMMUNOASSAY
- K Number
- K862838
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cytotech, Inc.
- Date Received
- July 25, 1986
- Decision Date
- December 9, 1986
- Product Code
- GCO
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCO | Endoscope, Mirror | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCO), ordered by most recent decision date.
HAND MIRROR (ENDOSCOPE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DELTA-ROL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cytotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Aug 4, 1988 | Substantially Equivalent |
| K874379 | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | Nov 25, 1987 | Substantially Equivalent |
| K873249 | ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS | Sep 22, 1987 | Substantially Equivalent |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Jul 23, 1987 | Substantially Equivalent |
| K871801 | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT | Jun 9, 1987 | Substantially Equivalent |
| K864315 | CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY | Feb 2, 1987 | Substantially Equivalent |
| K863363 | CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY | Nov 13, 1986 | Substantially Equivalent |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Sep 4, 1986 | Substantially Equivalent |
| K860493 | CYTOTECH CMV IGG EIA | May 20, 1986 | Substantially Equivalent |