510(k) K812365
- Device
- PARA 1 SENDAI HEMAGGLUTININ
- Applicant
- DUTCHLAND LABORATORIES, INC.
- 510(k) number
- K812365
- Product code
- GQR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-09
- Date received
- 1981-08-20
- Regulation
- 866.3400
- Classification name
- Antigens, Ha (including Ha Control), Parainfluenza Virus 1-4
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013530901
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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