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510(k) K861893

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) by Hi Chem, Inc. — Product Code JXL

K861893 is an FDA 510(k) premarket notification submitted by Hi Chem, Inc. for the device "GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)". The FDA issued a decision of Substantially Equivalent on June 5, 1986. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Hi Chem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1986
Date Received
May 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
Submission Type

Other clearances by Hi Chem, Inc.

  • K960084 — HICHEM GLUCOSE/HK REAGENT KIT (April 4, 1996)
  • K951818 — HICHEM ALT REAGENT KIT (May 15, 1995)
  • K943684 — HICHEM ENZYME VERIFIER KIT (October 4, 1994)
  • K941764 — HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (May 13, 1994)
  • K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (July 17, 1990)
  • K863617 — ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (October 24, 1986)
  • K862027 — LDP REAGENT CARTRIDGE (NO. 88216) (June 13, 1986)
  • K861879 — CK REAGENT CARTRIDGE (PRODUCT NO. 88213) (May 29, 1986)
  • K861419 — HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE (April 28, 1986)
  • K861284 — AP REAGENT CARTRIDGE (April 28, 1986)

Other clearances for product code JXL

  • K221469 — PATI (Protector Against Tongue Injury) (February 22, 2023)
  • K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (June 4, 2021)
  • K172978 — SurgeoBite (December 22, 2017)
  • K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and To (June 29, 2015)
  • K050188 — EPIGUARD (April 27, 2005)
  • K992269 — VENTIL-A ORAL PROTECTOR (October 25, 1999)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K954352 — BITE BLOCK (January 25, 1996)
  • K941856 — PREMIER PROMAX BITE GUARD (April 5, 1995)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)

FDA data resources