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FDA 510(k)

S/P VORTEX MIXER JR.

K-Number: K813149 · 1981-11-24

ApplicantAmerican Dade
Decision Date1981-11-24
Product CodeJRQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S/P VORTEX MIXER JR. is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813149. The device is classified under product code JRQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S/P VORTEX MIXER JR.?

S/P VORTEX MIXER JR. is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is American Dade. The 510(k) number is K813149.

When did S/P VORTEX MIXER JR. receive FDA 510(k) clearance?

S/P VORTEX MIXER JR. received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813149.

Who is the listed applicant for S/P VORTEX MIXER JR.?

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

What is the FDA product code for S/P VORTEX MIXER JR.?

The FDA product code for S/P VORTEX MIXER JR. is JRQ.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: JRQ)

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.

K813318MINI-SHAKERDynatech Corp.K813148S/P VORTEX MIXERAmerican DadeK801145SMI MULTI-TUBE VORTEXERScientific Manufacturing IndustriesK790753DIMENSIONALL ROTATORAmerican Hospital Supply Corp.K790027SHAKER, MODEL SH-510Sysmex Corp.K780543THERMAJUST CIRCU-TEMPTechhnilab Instruments, 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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