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FDA 510(k)

MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)

K-Number: K895555 · 1989-12-22

ApplicantHichem Diagnostics
Decision Date1989-12-22
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K895555. The device is classified under product code CJA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)?

MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Hichem Diagnostics. The 510(k) number is K895555.

When did MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) receive FDA 510(k) clearance?

MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) received FDA 510(k) clearance on 1989-12-22, under 510(k) number K895555.

Who is the listed applicant for MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)?

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 MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)?

The FDA product code for MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) is CJA.

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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 70008K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011K953862HICHEM ISEKCI SOLUTION KIT 70010

View all 41 devices →

Related Devices (Code: CJA)

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.

K884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.K883059WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.K873520PARAMAX AMYLASE REAGENTBaxter Healthcare CorpK862640AMYLASE LTSElectro-Nucleonics Laboratories, Inc.K863052ALPHA AMYLASEJ. D. Assoc.K860530AMYLASE REAGENT SET (MODIFIED CARAWAY)Sterling Diagnostics, Inc.

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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