510(k) K023032
- Device
- LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
- Applicant
- BIORESOURCE TECHNOLOGY, INC.
- 510(k) number
- K023032
- Product code
- GFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-08
- Date received
- 2002-09-11
- Regulation
- 864.8625
- Classification name
- Standards And Controls, Hemoglobin, Normal And Abnormal
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN POSNER
- Address
- 1531 NW 65th Ave. Fort Lauderdale FL US 33313 33313
FDA Registration Numbers#
- 3002637618
- 3014150341
- 3023162659
- 1219029
- 1220649
- 2432235
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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