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FDA 510(k)

CHEMCODE/CHEMTEK SYSTEM

K-Number: K771496 · 1977-10-25

ApplicantBoehringer Mannheim Corp.
Decision Date1977-10-25
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMCODE/CHEMTEK SYSTEM 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 1977-10-25 under 510(k) number K771496. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMCODE/CHEMTEK SYSTEM?

CHEMCODE/CHEMTEK SYSTEM is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K771496.

When did CHEMCODE/CHEMTEK SYSTEM receive FDA 510(k) clearance?

CHEMCODE/CHEMTEK SYSTEM received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771496.

Who is the listed applicant for CHEMCODE/CHEMTEK SYSTEM?

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 CHEMCODE/CHEMTEK SYSTEM?

The FDA product code for CHEMCODE/CHEMTEK SYSTEM is JJQ.

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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 SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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