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FDA 510(k)

AMYLASE LTS

K-Number: K862640 · 1986-09-09

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1986-09-09
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE LTS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1986-09-09 under 510(k) number K862640. 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 LTS?

AMYLASE LTS is a medical device that received FDA 510(k) clearance on 1986-09-09. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K862640.

When did AMYLASE LTS receive FDA 510(k) clearance?

AMYLASE LTS received FDA 510(k) clearance on 1986-09-09, under 510(k) number K862640.

Who is the listed applicant for AMYLASE LTS?

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

What is the FDA product code for AMYLASE LTS?

The FDA product code for AMYLASE LTS is CJA.

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Other records listing Electro-Nucleonics Laboratories, 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.

K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISA

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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.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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