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FDA 510(k)

SYNERGY SCREEN TEST, MODIFICATION

K-Number: K921977 · 1993-10-12

ApplicantBaxter Healthcare Corp
Decision Date1993-10-12
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYNERGY SCREEN TEST, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K921977. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGY SCREEN TEST, MODIFICATION?

SYNERGY SCREEN TEST, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K921977.

When did SYNERGY SCREEN TEST, MODIFICATION receive FDA 510(k) clearance?

SYNERGY SCREEN TEST, MODIFICATION received FDA 510(k) clearance on 1993-10-12, under 510(k) number K921977.

Who is the listed applicant for SYNERGY SCREEN TEST, MODIFICATION?

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

What is the FDA product code for SYNERGY SCREEN TEST, MODIFICATION?

The FDA product code for SYNERGY SCREEN TEST, MODIFICATION is LRG.

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Other records listing Baxter Healthcare Corp as applicant

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K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

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Related Devices (Code: LRG)

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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, Inc.

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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