510(k) K811178
- Device
- HUMAN IGG-ALBUMIN TEST KIT
- Applicant
- MELOY LABORATORIES, INC.
- 510(k) number
- K811178
- Product code
- CJQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-15
- Date received
- 1981-04-28
- Regulation
- 862.1035
- Classification name
- Radial Immunodiffusion, Albumin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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