Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E) Hemoglobin(E), Mini Acid(E) Hemo)

• • Terminated Z-0073-2007 FDA Unclassified (pre-2012) ·initiated 29 Aug 2006

  The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

510(k) Number

K991362 ↗

FDA Product Code

JBD

Device Class

Class II

Regulation

21 CFR Part 864.7440

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hydragel Csf Isofocusing Kits

  Class II

  FDA 510(k) K033277 Active Cleared 4 Nov 2003

• Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit

  Class II

  FDA 510(k) K972591 Active Cleared 4 Mar 1998

• Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15, 30 Protein Kit

  Class I

  FDA 510(k) K960029 Active Cleared 17 Jul 1996

• Hydragel 6 Csf Kit

  Class II

  FDA 510(k) K981048 Active Cleared 7 Oct 1998

• Hydragel-Mini Iso-Ck Kit, Hydragel Iso-Ck Kit, Hydragel 7 IS0-Ck Kit, Hydragel Iso-Ck 15/30 Kit

  Class II

  FDA 510(k) K992148 Active Cleared 29 Dec 1999

• Hydragel If, 6 If, 12 If Penta Kits/Hydragel If, Double If, 2 If, & 4 If Kits

  Class II

  FDA 510(k) K960669 Active Cleared 12 Jul 1996

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