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FDA 510(k)

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

K-Number: K884226 · 1988-12-09

ApplicantA-Kem, Inc.
Decision Date1988-12-09
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1988-12-09 under 510(k) number K884226. 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 AMYLASE REAGENT KIT FOR ASTRA SYSTEMS?

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS is a medical device that received FDA 510(k) clearance on 1988-12-09. The listed applicant is A-Kem, Inc.. The 510(k) number is K884226.

When did AMYLASE REAGENT KIT FOR ASTRA SYSTEMS receive FDA 510(k) clearance?

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS received FDA 510(k) clearance on 1988-12-09, under 510(k) number K884226.

Who is the listed applicant for AMYLASE REAGENT KIT FOR ASTRA SYSTEMS?

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

What is the FDA product code for AMYLASE REAGENT KIT FOR ASTRA SYSTEMS?

The FDA product code for AMYLASE REAGENT KIT FOR ASTRA SYSTEMS is CJA.

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Other records listing A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEMK882587A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEMK873132BUN REAGENT KIT

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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.

K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem DiagnosticsK883059WAKO(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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