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FDA 510(k)

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

K-Number: K863617 · 1986-10-24

ApplicantHi Chem, Inc.
Decision Date1986-10-24
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863617. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)?

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Hi Chem, Inc.. The 510(k) number is K863617.

When did ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) receive FDA 510(k) clearance?

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863617.

Who is the listed applicant for ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)?

The FDA 510(k) record lists Hi Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)?

The FDA product code for ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) is JGS.

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Other records listing Hi Chem, Inc. as applicant

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K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK862027LDP REAGENT CARTRIDGE (NO. 88216)

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Related Devices (Code: JGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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