510(k) K780281
- Device
- IMMUFUGE DISP. LINER
- Applicant
- DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
- 510(k) number
- K780281
- Product code
- KSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-03-02
- Date received
- 1978-02-21
- Regulation
- 864.9275
- Classification name
- Centrifuge, Blood-bank For In Vitro Diagnostic Use
- Medical specialty
- Hematology
- Review panel
- Hematology
- 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#
- 3012315023
- 3014325803
- 3005990076
- 3010825766
- 8010672
- 3014150341
- 3013894805
- 3012942167
- 3006897996
- 3042991841
- 3023346439
- 1066491
- 3013846070
- 3021169199
- 3031700059
- 9613910
- 3013660430
- 3014060475
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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