510(k) K872700
- Device
- YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
- Applicant
- SITA, INC.
- 510(k) number
- K872700
- Product code
- GPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-15
- Date received
- 1987-07-07
- Regulation
- 866.3120
- Classification name
- Antigen, Cf, Psittacosis (chlamydia Group)
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANIS F CHARLTON
- Address
- Regulatory Affairs Dept. 130 So. Main St. Allentown NJ US 08501 08501
FDA Registration Numbers#
- 2032682
- 1181055
- 3043196750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GPW #
Legacy Summary#
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FDA Review#
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