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FDA 510(k)

SCRIPPSERA COMPLEMENT CONTROL SERA

K-Number: K811433 · 1981-06-16

ApplicantScripps-Miles, Inc.
Decision Date1981-06-16
Product CodeDHL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCRIPPSERA COMPLEMENT CONTROL SERA is the device name listed in this FDA 510(k) record. The listed applicant is Scripps-Miles, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811433. The device is classified under product code DHL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCRIPPSERA COMPLEMENT CONTROL SERA?

SCRIPPSERA COMPLEMENT CONTROL SERA is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Scripps-Miles, Inc.. The 510(k) number is K811433.

When did SCRIPPSERA COMPLEMENT CONTROL SERA receive FDA 510(k) clearance?

SCRIPPSERA COMPLEMENT CONTROL SERA received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811433.

Who is the listed applicant for SCRIPPSERA COMPLEMENT CONTROL SERA?

The FDA 510(k) record lists Scripps-Miles, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCRIPPSERA COMPLEMENT CONTROL SERA?

The FDA product code for SCRIPPSERA COMPLEMENT CONTROL SERA is DHL.

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Other records listing Scripps-Miles, 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.

K812453SCRIPPSYSTEM IMMUNOGLOBIN RID KITK812328SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KITK811714HEP-2-CRITHIDIA LUCILIAE ANA TEST KITK810501SCRIPPSYSTEM C3 RID KITK810502SCRIPPSYSTEM C4 RID KITK810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

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Related Devices (Code: DHL)

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.

K870351EZ COMPLEMENT REAGENTS, 78N2212Diamedix Corp.K811445KALLESTAD R QUANTIPLATE ALT. PATHWAY T.Kallestad Laboratories, Inc.K770866RABBIT COMPLEMENTCedarlake Labs , Ltd.

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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