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FDA 510(k)

DC-LINEATE CAT. NO. SE-091

K-Number: K932555 · 1993-08-19

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1993-08-19
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DC-LINEATE CAT. NO. SE-091 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K932555. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DC-LINEATE CAT. NO. SE-091?

DC-LINEATE CAT. NO. SE-091 is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K932555.

When did DC-LINEATE CAT. NO. SE-091 receive FDA 510(k) clearance?

DC-LINEATE CAT. NO. SE-091 received FDA 510(k) clearance on 1993-08-19, under 510(k) number K932555.

Who is the listed applicant for DC-LINEATE CAT. NO. SE-091?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-LINEATE CAT. NO. SE-091?

The FDA product code for DC-LINEATE CAT. NO. SE-091 is JIS.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K925877DC-UIBC-CALK912825MAGNESIUM ASSAY KIT, CAT.# 100-12

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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