FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBAZYME - M
K Number: K810835
·
Decision May 5, 1981
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
883
Review Days
41
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
- RUBAZYME - M
- K Number
- K810835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- March 25, 1981
- Decision Date
- May 5, 1981
- Product Code
- GOK
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| GOK | Antisera, Hai (Including Hai Control), Rubella | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GOK), ordered by most recent decision date.
RUBASCAN LATEX CARD TEST
FDA 510(k)
FDA Class 2
·Microbiology
ANTIBODY TO RUBELLA VIRUS
FDA 510(k)
FDA Class 2
·Microbiology
RUBELISA TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
RUBANON
FDA 510(k)
FDA Class 2
·Microbiology
RUBINDEX*DIRECT SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
CYTOMEGILISH TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |