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510(k) K800364

ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 by Hoffrel Instruments, Inc. — Product Code DKX

K800364 is an FDA 510(k) premarket notification submitted by Hoffrel Instruments, Inc. for the device "ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code DKX (Thin Layer Chromatography, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Hoffrel Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
February 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Hoffrel Instruments, Inc.

  • K870850 — MOD 482 (September 8, 1987)
  • K860235 — MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER (May 15, 1986)
  • K850165 — MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (October 23, 1985)
  • K844916 — MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER (April 22, 1985)
  • K834276 — MOD 456 (February 17, 1984)
  • K834277 — MOD 427 (February 17, 1984)
  • K837282 — MODEL VPS VASCULAR PROFILE SYSTEM (April 26, 1983)
  • K837229 — TRANSDUCER MODELS 450, 451, 452, 453, 454 (April 15, 1983)
  • K837142 — TRANSDUCERS MODELS 421, 419 AND 420 FOR IREX SYSTEM (March 23, 1983)
  • K790396 — ULTRASONIC DIAGNOSTIC SYSTEM (March 21, 1979)

Other clearances for product code DKX

  • K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (June 13, 2003)

FDA data resources