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FDA 510(k)

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION

K-Number: K940048 · 1996-03-19

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1996-03-19
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare Technologies Corp,Inc.. It received FDA 510(k) clearance on 1996-03-19 under 510(k) number K940048. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION?

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION is a medical device that received FDA 510(k) clearance on 1996-03-19. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K940048.

When did STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION receive FDA 510(k) clearance?

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION received FDA 510(k) clearance on 1996-03-19, under 510(k) number K940048.

Who is the listed applicant for STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION?

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

What is the FDA product code for STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION?

The FDA product code for STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION is DLJ.

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Other records listing Solarcare Technologies Corp,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.

K954326STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAYK954156STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAYK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYK954158STC DIAGNOSTICS AUTO-LYTE PH ASSAYK954073STC DIAGNOSTICS LSD MICRO-PLATE EIAK954266STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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