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FDA 510(k)

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)

K-Number: K902155 · 1990-06-12

ApplicantHichem Diagnostics
Decision Date1990-06-12
Product CodeJIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K902155. The device is classified under product code JIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)?

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Hichem Diagnostics. The 510(k) number is K902155.

When did HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) receive FDA 510(k) clearance?

HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) received FDA 510(k) clearance on 1990-06-12, under 510(k) number K902155.

Who is the listed applicant for HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)?

The FDA product code for HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) is JIM.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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Related Devices (Code: JIM)

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.

K790772CHEMTABBoehringer Mannheim Corp.

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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