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FDA 510(k)

IMMUNOCHEMISTRY SYS. MANUAL MODE

K-Number: K781006 · 1978-08-31

ApplicantBeckman Instruments, Inc.
Decision Date1978-08-31
Product CodeJZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOCHEMISTRY SYS. MANUAL MODE is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781006. The device is classified under product code JZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCHEMISTRY SYS. MANUAL MODE?

IMMUNOCHEMISTRY SYS. MANUAL MODE is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K781006.

When did IMMUNOCHEMISTRY SYS. MANUAL MODE receive FDA 510(k) clearance?

IMMUNOCHEMISTRY SYS. MANUAL MODE received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781006.

Who is the listed applicant for IMMUNOCHEMISTRY SYS. MANUAL MODE?

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

What is the FDA product code for IMMUNOCHEMISTRY SYS. MANUAL MODE?

The FDA product code for IMMUNOCHEMISTRY SYS. MANUAL MODE is JZW.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

View all 281 devices →

Related Devices (Code: JZW)

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.

K001647BN PROSPEC SYSTEMDade Behring, Inc.K761234BEHRING LASER NEPHELOMETERBehring Diagnostics, Inc.K892223BEHRING NEPHELOMETER 100Behring Diagnostics, Inc.K873407RRT SYSTEM LASER REFLECTOMETER ANALYZERIncstar Corp.K873401TURBOXUnipath , Ltd.K801949BCM-302 COLLIMATING CONE & COMPENSATINB C Medical , 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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