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FDA 510(k)

QM300 CALIBRATOR D PACK

K-Number: K881127 · 1988-04-21

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-04-21
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QM300 CALIBRATOR D PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-04-21 under 510(k) number K881127. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QM300 CALIBRATOR D PACK?

QM300 CALIBRATOR D PACK is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K881127.

When did QM300 CALIBRATOR D PACK receive FDA 510(k) clearance?

QM300 CALIBRATOR D PACK received FDA 510(k) clearance on 1988-04-21, under 510(k) number K881127.

Who is the listed applicant for QM300 CALIBRATOR D PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QM300 CALIBRATOR D PACK?

The FDA product code for QM300 CALIBRATOR D PACK is DCF.

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Other records listing Kallestad Diag, A Div. of Erbamont, 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.

K910887QM300 CONTROL G PACKK910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.

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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