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FDA 510(k)

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)

K-Number: K895585 · 1989-11-13

ApplicantHichem Diagnostics
Decision Date1989-11-13
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K895585. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)?

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Hichem Diagnostics. The 510(k) number is K895585.

When did HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) receive FDA 510(k) clearance?

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) received FDA 510(k) clearance on 1989-11-13, under 510(k) number K895585.

Who is the listed applicant for HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)?

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 TRIGLYCERIDES CALIBRATOR E (88185)?

The FDA product code for HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) is JIS.

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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: JIS)

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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