510(k) K790997
- Device
- ANTI-DNASE B REAGENT SYSTEM
- Applicant
- CALBIOCHEM-BEHRING CORP.
- 510(k) number
- K790997
- Product code
- GTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-07-24
- Date received
- 1979-05-29
- Regulation
- 866.3720
- Classification name
- Antideoxyribonuclease, Streptococcus Spp.
- 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#
- 2050012
- 2050010
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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