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FDA 510(k)

AP REAGENT CARTRIDGE

K-Number: K861284 · 1986-04-28

ApplicantHi Chem, Inc.
Decision Date1986-04-28
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AP REAGENT CARTRIDGE 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 1986-04-28 under 510(k) number K861284. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AP REAGENT CARTRIDGE?

AP REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Hi Chem, Inc.. The 510(k) number is K861284.

When did AP REAGENT CARTRIDGE receive FDA 510(k) clearance?

AP REAGENT CARTRIDGE received FDA 510(k) clearance on 1986-04-28, under 510(k) number K861284.

Who is the listed applicant for AP REAGENT CARTRIDGE?

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 AP REAGENT CARTRIDGE?

The FDA product code for AP REAGENT CARTRIDGE is CJE.

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Other records listing Hi Chem, Inc. as applicant

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.

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 STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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Related Devices (Code: CJE)

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.

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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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