FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
K Number: K905306
·
Decision Jun 17, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
5
Review Days
201
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Basic Information
- Device Name
- MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
- K Number
- K905306
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Virion (U.S.), Inc.
- Date Received
- November 28, 1990
- Decision Date
- June 17, 1991
- Product Code
- GRC
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRC), ordered by most recent decision date.
MUMPS COMPLEMENT FIXATION & HEMAGGLU
FDA 510(k)
FDA Class 1
·Microbiology
MUMPS S & V ANTIGENS & CONTROLS
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Virion (U.S.), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | Jun 13, 1994 | Substantially Equivalent |
| K921618 | COXSACKIE VIRUS B1-B6 CF ANTIGENS | Jun 29, 1992 | Substantially Equivalent |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | Mar 21, 1991 | Substantially Equivalent |
| K864981 | TOXOPLASMA GONDII | Oct 30, 1987 | Substantially Equivalent |