Decision Date1982-02-10
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
DAKO PAP KIT K504 is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1982-02-10 under 510(k) number K812485. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DAKO PAP KIT K504?
DAKO PAP KIT K504 is a medical device that received FDA 510(k) clearance on 1982-02-10. The listed applicant is Dako Corp.. The 510(k) number is K812485.
When did DAKO PAP KIT K504 receive FDA 510(k) clearance?
DAKO PAP KIT K504 received FDA 510(k) clearance on 1982-02-10, under 510(k) number K812485.
Who is the listed applicant for DAKO PAP KIT K504?
The FDA 510(k) record lists Dako Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DAKO PAP KIT K504?
The FDA product code for DAKO PAP KIT K504 is DFH.
Other records listing Dako 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.
K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGK993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTORK991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1K991454MOUSE IGG1 NEGATIVE CONTROLSK980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING View all 54 devices →
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Official Source
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