FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
K Number: K872700
·
Decision Oct 15, 1987
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
9
Review Days
100
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Basic Information
- Device Name
- YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
- K Number
- K872700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Sita, Inc.
- Date Received
- July 7, 1987
- Decision Date
- October 15, 1987
- Product Code
- GPW
- 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 |
|---|---|---|---|
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GPW), ordered by most recent decision date.
CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
CHLAMYDIA GROUP CF ANTIGEN
FDA 510(k)
FDA Class 1
·Microbiology
ANTIBODY TO CHLAMYDIA TRACHOMATIS
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Sita, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872698 | ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872697 | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872695 | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872699 | MUMPS CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | Sep 18, 1987 | Substantially Equivalent |
| K872696 | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent |