FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEASLES VIRUS RUBEOLA
K Number: K843662
·
Decision Sep 26, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
16
Review Days
374
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEASLES VIRUS RUBEOLA
- K Number
- K843662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3520
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- September 17, 1984
- Decision Date
- September 26, 1985
- Product Code
- GRJ
- 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 |
|---|---|---|---|
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRJ), ordered by most recent decision date.
View allOther Clearances by Institute Virion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Sep 30, 1986 | Substantially Equivalent |
| K843665 | PARAINFLUENZA 1 | Sep 26, 1985 | Substantially Equivalent |
| K843649 | ADENOVIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843658 | H. SIMPLEX VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843657 | CYTOMEGALOVIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843667 | PARAINFLUENZA 3 | Sep 26, 1985 | Substantially Equivalent |
| K843660 | IN FLUENZA B VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843659 | INFLUENZA A2 VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843676 | VARICELLA/ZOSTER VIRUS | Sep 26, 1985 | Substantially Equivalent |