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FDA 510(k)

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET

K-Number: K881773 · 1988-06-10

ApplicantCasco Standards
Decision Date1988-06-10
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K881773. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET?

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Casco Standards. The 510(k) number is K881773.

When did DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET receive FDA 510(k) clearance?

DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881773.

Who is the listed applicant for DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET?

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

What is the FDA product code for DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET?

The FDA product code for DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET is JJR.

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Other records listing Casco Standards 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.

K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLK962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORK961750DOCUMENT CARDIAC ASSAYED CONTROLK962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLK960244DOCUMENT TDM ULTRA ASSAYED CONTROL

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Related Devices (Code: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat 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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