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510(k) K872834

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 by Helena Laboratories — Product Code CZJ

K872834 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410". The FDA issued a decision of Substantially Equivalent on August 12, 1987. The device falls under product code CZJ (Igd, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1987
Date Received
July 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igd, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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 CZJ

  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K051299 — IGD DIAGNOSTIC TEST KITS (November 23, 2005)
  • K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (October 26, 2000)
  • K913671 — HUMAN IGD IMMUNOLOGICAL NL TEST KIT (December 2, 1991)
  • K883001 — QM300 CALIBRATOR D PACK (September 22, 1988)
  • K831956 — DETERM. SIZE 72 RADIAL-HUMAN IGD (July 18, 1983)
  • K772327 — LAS-R HUMAN IGD TEST (February 28, 1978)

FDA data resources