Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K974854 ↗

FDA Product Code

JHO

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

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

  Class II

  FDA 510(k) K991362 Active Cleared 21 Jun 1999

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