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FDA 510(k)

ELECSYS PRECICONTROL TSH

K-Number: K962573 · 1996-07-22

ApplicantBoehringer Mannheim Corp.
Decision Date1996-07-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS PRECICONTROL TSH 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 1996-07-22 under 510(k) number K962573. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS PRECICONTROL TSH?

ELECSYS PRECICONTROL TSH is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K962573.

When did ELECSYS PRECICONTROL TSH receive FDA 510(k) clearance?

ELECSYS PRECICONTROL TSH received FDA 510(k) clearance on 1996-07-22, under 510(k) number K962573.

Who is the listed applicant for ELECSYS PRECICONTROL TSH?

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 PRECICONTROL TSH?

The FDA product code for ELECSYS PRECICONTROL TSH is JJX.

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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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