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510(k) K921578

TITAN GEL ALKALINE PHOSPHATASE (HR) by Helena Laboratories — Product Code CIN

K921578 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL ALKALINE PHOSPHATASE (HR)". The FDA issued a decision of Substantially Equivalent on September 23, 1992. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1992
Date Received
April 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Helena Laboratories

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  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

Other clearances for product code CIN

  • K232904 — Access Ostase (April 15, 2024)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (May 6, 2002)
  • K011113 — HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PA (June 13, 2001)
  • K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (March 28, 2000)
  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 1998)
  • K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (September 11, 1997)
  • K964764 — OPUS BONE ALP (January 24, 1997)
  • K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (August 19, 1996)

FDA data resources