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FDA 510(k)

REFLOTRON SYSTEM

K-Number: K852133 · 1985-09-16

ApplicantBoehringer Mannheim Corp.
Decision Date1985-09-16
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON 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 1985-09-16 under 510(k) number K852133. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON SYSTEM?

REFLOTRON SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K852133.

When did REFLOTRON SYSTEM receive FDA 510(k) clearance?

REFLOTRON SYSTEM received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852133.

Who is the listed applicant for REFLOTRON 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 REFLOTRON SYSTEM?

The FDA product code for REFLOTRON SYSTEM is JJE.

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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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Related Devices (Code: JJE)

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.

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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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