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FDA 510(k)

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311

K-Number: K922770 · 1992-08-18

ApplicantLeica, Inc.
Decision Date1992-08-18
Product CodeMQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 is the device name listed in this FDA 510(k) record. The listed applicant is Leica, Inc.. It received FDA 510(k) clearance on 1992-08-18 under 510(k) number K922770. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311?

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Leica, Inc.. The 510(k) number is K922770.

When did UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 receive FDA 510(k) clearance?

UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 received FDA 510(k) clearance on 1992-08-18, under 510(k) number K922770.

Who is the listed applicant for UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311?

The FDA 510(k) record lists Leica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311?

The FDA product code for UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 is MQM.

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Other records listing Leica, Inc. 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.

K951054XCEL SLIT LAMPK944022LENSCHEK

Related Devices (Code: MQM)

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.

K170882ABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical ApsK110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare DiagnosticsK073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions DiagnosticsK042522JAUNDICE METER, MODEL JM 103Draeger Medical Infant Care, Inc.K040174BILIRUBIN ASSAY ON THE OMNI S ANALYZERRoche Diagnostics Corp.K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103Hill-Rom Air-Shields

Official Source

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