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FDA 510(k)

IRON SYSTEM PACK REAGENTS

K-Number: K892838 · 1989-06-16

ApplicantBoehringer Mannheim Corp.
Decision Date1989-06-16
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON SYSTEM PACK REAGENTS 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 1989-06-16 under 510(k) number K892838. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON SYSTEM PACK REAGENTS?

IRON SYSTEM PACK REAGENTS is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K892838.

When did IRON SYSTEM PACK REAGENTS receive FDA 510(k) clearance?

IRON SYSTEM PACK REAGENTS received FDA 510(k) clearance on 1989-06-16, under 510(k) number K892838.

Who is the listed applicant for IRON SYSTEM PACK REAGENTS?

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 IRON SYSTEM PACK REAGENTS?

The FDA product code for IRON SYSTEM PACK REAGENTS is JIY.

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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: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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