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510(k) K810968

BCD-HPP41C INTERFACE by Dynatech Corp. — Product Code JQP

K810968 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "BCD-HPP41C INTERFACE". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Dynatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

Other clearances by Dynatech Corp.

  • K904567 — DYNATECH MR4000 MICROPLATE READER (January 28, 1991)
  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • K832117 — IMMULON SUBSTRATE REMOVAWELL STRIPS (August 8, 1983)
  • K823787 — HANDI-WASH (March 9, 1983)
  • K823833 — MICRO STIX #011-010-5000 & HOLDER#5100 (March 8, 1983)
  • K830200 — MICROELISA MINIREADER II (February 16, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K823557 — REMOVAWELL PLATE LID (December 28, 1982)

Other clearances for product code JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)

FDA data resources