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FDA 510(k)

SCRIPPSYSTEM C4 RID KIT

K-Number: K810502 · 1981-04-08

ApplicantScripps-Miles, Inc.
Decision Date1981-04-08
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SCRIPPSYSTEM C4 RID KIT 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 1981-04-08 under 510(k) number K810502. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCRIPPSYSTEM C4 RID KIT?

SCRIPPSYSTEM C4 RID KIT is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Scripps-Miles, Inc.. The 510(k) number is K810502.

When did SCRIPPSYSTEM C4 RID KIT receive FDA 510(k) clearance?

SCRIPPSYSTEM C4 RID KIT received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810502.

Who is the listed applicant for SCRIPPSYSTEM C4 RID KIT?

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 SCRIPPSYSTEM C4 RID KIT?

The FDA product code for SCRIPPSYSTEM C4 RID KIT is DBI.

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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 KITK811433SCRIPPSERA COMPLEMENT CONTROL SERAK810501SCRIPPSYSTEM C3 RID KITK810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

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Related Devices (Code: DBI)

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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, 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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