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510(k) K821534

HEMATOLOGY DATA MANAGEMENT SYS by Biovation, Inc. — Product Code JGP

K821534 is an FDA 510(k) premarket notification submitted by Biovation, Inc. for the device "HEMATOLOGY DATA MANAGEMENT SYS". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code JGP (Lowry (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Biovation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lowry (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Biovation, Inc.

  • K925528 — BIOVATION K-MANAGER (February 5, 1993)
  • K923844 — LYRIS 100/120 LABORATORY INFORMATION SYSTEM (December 11, 1992)
  • K915071 — DIFFERENTIAL COUNTING BOARD (January 17, 1992)
  • K853026 — BIOVATION MAX DATA MANAGEMENT SYSTEM (August 2, 1985)
  • K842401 — CHEMISTRY CONSOLE (September 4, 1984)
  • K831830 — LYRIS MODULAR INFO SYSTEM (June 25, 1984)
  • K812604 — BIOVATION URINALYSIS REPORTER (October 2, 1981)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790862 — BIOVATION DIGITAL URINOMETER (June 28, 1979)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

Other clearances for product code JGP

  • K070757 — MICROPROTEIN REAGENT SET (December 4, 2007)
  • K964960 — VITROS CHEMISTRY PRODUCTS UPRO SLIDES (February 18, 1997)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K792347 — MICRO LOWRY PROTEINTEST (December 6, 1979)

FDA data resources