Home / 510(k) Clearances / K890057

510(k) K890057

SENSITITRE AUTO ID PLATE AP80 by Radiometer America, Inc. — Product Code LQM

K890057 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "SENSITITRE AUTO ID PLATE AP80". The FDA issued a decision of Substantially Equivalent on June 9, 1989. The device falls under product code LQM (Gram Negative Identification Panel), a Class I device regulated under 21 CFR 866.2660. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1989
Date Received
January 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Negative Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Radiometer America, Inc.

  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (January 10, 2000)
  • K991417 — ABL 735 ANALYZER (November 24, 1999)
  • K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (January 6, 1999)
  • K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (February 9, 1998)
  • K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (January 28, 1998)
  • K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (January 16, 1998)
  • K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (October 6, 1997)
  • K962158 — PICO MODELS 30, 50, 70 (October 29, 1996)
  • K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER (October 24, 1996)

Other clearances for product code LQM

  • K923313 — ROCHE OXI/FERM II (April 5, 1993)
  • K925915 — VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (March 23, 1993)
  • K912897 — SCEPTOR IDENTIFICATION SYSTEM (October 28, 1991)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 1991)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K851528 — PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (July 15, 1985)

FDA data resources