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FDA 510(k)

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)

K-Number: K902575 · 1990-10-04

ApplicantDiagnostic Products Corp.
Decision Date1990-10-04
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1990-10-04 under 510(k) number K902575. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)?

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) is a medical device that received FDA 510(k) clearance on 1990-10-04. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K902575.

When did SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) receive FDA 510(k) clearance?

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) received FDA 510(k) clearance on 1990-10-04, under 510(k) number K902575.

Who is the listed applicant for SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)?

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

What is the FDA product code for SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)?

The FDA product code for SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) is JIW.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: JIW)

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.

K973055WAKO CH50 LINEARITY SETWako Chemicals USA, Inc.K970396HUMAN CHORIONIC GONADOTROPIN CALIBRATORDade Chemistry Systems, Inc.K910255FLOW CYTOMETRY FITC/PE COMPENSATION KITSigma Diagnostics, Inc.K902294ACCUSCAN MICROBEAD STANDARDSSigma Chemical Co.K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.K883389RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, 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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