Home / 510(k) Clearances / K862848

510(k) K862848

LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 by Lkb Instruments, Inc. — Product Code GWC

K862848 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110". The FDA issued a decision of Substantially Equivalent on December 18, 1986. The device falls under product code GWC (Antisera, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1986
Date Received
July 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
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)
  • K863422 — DELFIA(TM) CORTISOL KIT (September 26, 1986)
  • K862044 — DELFIA (TM) HCG KIT (July 11, 1986)
  • K861195 — DELFIA DIGOXIN (July 11, 1986)

Other clearances for product code GWC

  • K884966 — BACTIGEN(R) S. PNEUMONIAE (February 7, 1989)
  • K884965 — BACTIGEN(R) MENINGITIDIS PANEL (February 7, 1989)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K842239 — VENTRESCREEN STREP A TEST (July 2, 1984)
  • K841376 — WELLCOGEN S. PNEUMONIAE (May 2, 1984)
  • K831887 — BACTIGEN S. PNEUMONIAE (September 26, 1983)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)

FDA data resources