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510(k) K812158

LKB-BROMMA 2188 ULTROTOME NOVA by Lkb Instruments, Inc. — Product Code IDM

K812158 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "LKB-BROMMA 2188 ULTROTOME NOVA". The FDA issued a decision of Substantially Equivalent on September 16, 1981. The device falls under product code IDM (Microtome, Ultra), a Class I device regulated under 21 CFR 864.3010. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1981
Date Received
July 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtome, Ultra
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Lkb Instruments, Inc.

  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872955 — DELFIA(TM) FERRITIN KIT (August 21, 1987)
  • K871303 — DELFIA(TM) THYROXINE (T4) KIT (June 17, 1987)
  • K871599 — DELFIA(TM) HIGE KIT (June 12, 1987)
  • K871644 — DELFIA (TM) HTSH KIT (May 12, 1987)
  • K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (February 2, 1987)
  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K863422 — DELFIA(TM) CORTISOL KIT (September 26, 1986)
  • K862044 — DELFIA (TM) HCG KIT (July 11, 1986)

FDA data resources