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510(k) K113731

ESENSOR RESPIRATORY VIRAL PANEL by Clinical Micro Sensors, Inc. — Product Code JJH

K113731 is an FDA 510(k) premarket notification submitted by Clinical Micro Sensors, Inc. for the device "ESENSOR RESPIRATORY VIRAL PANEL". The FDA issued a decision of Substantially Equivalent on September 10, 2012. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. Clinical Micro Sensors, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2012
Date Received
December 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clinical Sample Concentrator
Device Class
Class I
Regulation Number
862.2310
Review Panel
CH
Submission Type

Other clearances by Clinical Micro Sensors, Inc.

  • K060543 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 (March 28, 2006)
  • K051435 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYST (January 19, 2006)

Other clearances for product code JJH

  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K851393 — DUPONT PREP FOUR-SOLVENT RETROFIT KIT (July 12, 1985)

FDA data resources