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FDA 510(k)

ELECSYS IGE CALCHECK

K-Number: K984419 · 1999-02-02

ApplicantBoehringer Mannheim Corp.
Decision Date1999-02-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS IGE CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K984419. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS IGE CALCHECK?

ELECSYS IGE CALCHECK is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K984419.

When did ELECSYS IGE CALCHECK receive FDA 510(k) clearance?

ELECSYS IGE CALCHECK received FDA 510(k) clearance on 1999-02-02, under 510(k) number K984419.

Who is the listed applicant for ELECSYS IGE CALCHECK?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS IGE CALCHECK?

The FDA product code for ELECSYS IGE CALCHECK is JJY.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TESTK983503ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347

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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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