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FDA 510(k)

AMYLASE REAGENT SET-MODIFIED CARAWAY

K-Number: K833864 · 1984-01-13

ApplicantSterling Biochemical, Inc.
Decision Date1984-01-13
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE REAGENT SET-MODIFIED CARAWAY is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Biochemical, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833864. 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 SET-MODIFIED CARAWAY?

AMYLASE REAGENT SET-MODIFIED CARAWAY is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K833864.

When did AMYLASE REAGENT SET-MODIFIED CARAWAY receive FDA 510(k) clearance?

AMYLASE REAGENT SET-MODIFIED CARAWAY received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833864.

Who is the listed applicant for AMYLASE REAGENT SET-MODIFIED CARAWAY?

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

What is the FDA product code for AMYLASE REAGENT SET-MODIFIED CARAWAY?

The FDA product code for AMYLASE REAGENT SET-MODIFIED CARAWAY is CJA.

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Other records listing Sterling Biochemical, 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.

K844998GLUCOSE(HEXOKINASE) REAGENT SETK844251ALT/GPT REAGENT SETK843332ALKALINE PHOSPHATASE REAGENT SETK842521AST/GOT REAGENT SET UV RATEK840064UREA NITROGEN REAGENT SETK834084HYDROXYBUTYRATE DEHYDROGENASE REAGENT

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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 DiagnosticsK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.K883059WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.K873520PARAMAX AMYLASE REAGENTBaxter Healthcare CorpK863052ALPHA AMYLASEJ. D. Assoc.K862640AMYLASE LTSElectro-Nucleonics Laboratories, 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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