FDA 510(k)

HEMATOLOGY DATA MANAGEMENT SYS

K-Number: K821534 · 1982-06-10

Decision Date1982-06-10

Product CodeJGP

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY DATA MANAGEMENT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Biovation, Inc.. It received FDA 510(k) clearance on 1982-06-10 under 510(k) number K821534. The device is classified under product code JGP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOLOGY DATA MANAGEMENT SYS?

HEMATOLOGY DATA MANAGEMENT SYS is a medical device that received FDA 510(k) clearance on 1982-06-10. The listed applicant is Biovation, Inc.. The 510(k) number is K821534.

When did HEMATOLOGY DATA MANAGEMENT SYS receive FDA 510(k) clearance?

HEMATOLOGY DATA MANAGEMENT SYS received FDA 510(k) clearance on 1982-06-10, under 510(k) number K821534.

Who is the listed applicant for HEMATOLOGY DATA MANAGEMENT SYS?

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

What is the FDA product code for HEMATOLOGY DATA MANAGEMENT SYS?

The FDA product code for HEMATOLOGY DATA MANAGEMENT SYS is JGP.

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Other records listing Biovation, Inc. as applicant

K925528BIOVATION K-MANAGER K923844LYRIS 100/120 LABORATORY INFORMATION SYSTEM K915071DIFFERENTIAL COUNTING BOARD K853026BIOVATION MAX DATA MANAGEMENT SYSTEM K842401CHEMISTRY CONSOLE K831830LYRIS MODULAR INFO SYSTEM

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Related Devices (Code: JGP)

K070757MICROPROTEIN REAGENT SETPointe Scientific, Inc.,K964960VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.K863112PROTEINMETERJ. D. Assoc.K792347MICRO LOWRY PROTEINTESTPanmed, 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.