FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPLASMA PNEUMONIAE
K Number: K843664
·
Decision Oct 25, 1984
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
16
Review Days
38
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Basic Information
- Device Name
- MYCOPLASMA PNEUMONIAE
- K Number
- K843664
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- September 17, 1984
- Decision Date
- October 25, 1984
- Product Code
- GSB
- 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 |
|---|---|---|---|
| GSB | Antigens, Cf, All, Mycoplasma Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GSB), ordered by most recent decision date.
MYCOPLASMA SPP SEROLOGICAL REAGENTS
FDA 510(k)
FDA Class 1
·Microbiology
MYCOPLASMA PNEUMONIAE CF ANTIGEN
FDA 510(k)
FDA Class 1
·Microbiology
SERA-TEK MYCOPLASMA ANTIBODY TEST
FDA 510(k)
FDA Class 1
·Microbiology
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Other 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 |
| K843662 | MEASLES VIRUS RUBEOLA | 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 |