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FDA 510(k)

QMS(TM) - THEOPHYLLINE

K-Number: K885263 · 1989-03-28

ApplicantSeradyn, Inc.
Decision Date1989-03-28
Product CodeJQX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QMS(TM) - THEOPHYLLINE is the device name listed in this FDA 510(k) record. The listed applicant is Seradyn, Inc.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K885263. The device is classified under product code JQX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QMS(TM) - THEOPHYLLINE?

QMS(TM) - THEOPHYLLINE is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Seradyn, Inc.. The 510(k) number is K885263.

When did QMS(TM) - THEOPHYLLINE receive FDA 510(k) clearance?

QMS(TM) - THEOPHYLLINE received FDA 510(k) clearance on 1989-03-28, under 510(k) number K885263.

Who is the listed applicant for QMS(TM) - THEOPHYLLINE?

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

What is the FDA product code for QMS(TM) - THEOPHYLLINE?

The FDA product code for QMS(TM) - THEOPHYLLINE is JQX.

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Other records listing Seradyn, 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.

K070645SERADYN QMS TOPIRAMATEK062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062204ARCHITECT CORTISOL ASSAYK060998QMS TOBRAMYCINK060709MULTIGENT GENTAMICINK052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

View all 28 devices →

Related Devices (Code: JQX)

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.

K962294IMMAGE IMMUNOCHEMISTRY SYSTEMBeckman Instruments, Inc.K922273ARRAY(R) 360Beckman Instruments, Inc.K851253TDX ANALYZER W/NEPHELOMETRY CAROUSELAbbott LaboratoriesK851234A-JUST TURBIDITY METERAbbott LaboratoriesK801362ALBUMIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.K801089J.T. BAKER NEPHELOMETERJ.T. Baker Chemical Co.

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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