510(k) K812919
- Device
- MULTI-GRAM DEVELOPING TANK R-12 & R-3
- Applicant
- MARION LABORATORIES, INC.
- 510(k) number
- K812919
- Product code
- DKK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-02
- Date received
- 1981-10-19
- Regulation
- 862.2270
- Classification name
- Tanks, Developing, Tlc
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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