FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INDIRECT FLUORESCENT ANTIBODY MYCO
K Number: K840012
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
4
Review Days
54
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
- INDIRECT FLUORESCENT ANTIBODY MYCO
- K Number
- K840012
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Technologies
- Date Received
- January 4, 1984
- Decision Date
- February 27, 1984
- Product Code
- GRZ
- 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 |
|---|---|---|---|
| GRZ | Antisera, Fluorescent, All, Mycoplasma Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRZ), ordered by most recent decision date.
MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ZEUA MYCOPLASMA
FDA 510(k)
FDA Class 1
·Microbiology
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
FDA 510(k)
FDA Class 1
·Microbiology
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
FDA 510(k)
FDA Class 1
·Microbiology