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FDA 510(k)

IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C

K-Number: K851828 · 1985-09-19

ApplicantSyncor Intl. Corp.
Decision Date1985-09-19
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K851828. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C?

IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K851828.

When did IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C receive FDA 510(k) clearance?

IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C received FDA 510(k) clearance on 1985-09-19, under 510(k) number K851828.

Who is the listed applicant for IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C?

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

What is the FDA product code for IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C?

The FDA product code for IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C is MOT.

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Other records listing Syncor Intl. 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.

K945825SECURE SAFETY INSERTK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K850433CESIUM 137 ENDOMETRIAL SOURCEK852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KITK844735PTH-RIA

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Related Devices (Code: MOT)

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.

K201177RadGil2R3 X-Ray L.L.CK181737Raycell MK1Best Theratronics LimitedK172087SANGRAYHitachi , Ltd.K161324Raycell Mk2Best Theratronics LimitedK082921RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400Rad Source Technologies, Inc.K051065RAYCELL X-RAY BLOOD IRRADIATORMds Nordion

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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