Home / 510(k) Clearances / K812558

510(k) K812558

TISSUE-TEK III ACCU-CUT ROTARY MICROTOME by Miles Laboratories, Inc. — Product Code IDO

K812558 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "TISSUE-TEK III ACCU-CUT ROTARY MICROTOME". The FDA issued a decision of Substantially Equivalent on September 29, 1981. The device falls under product code IDO (Microtome, Rotary), a Class I device regulated under 21 CFR 864.3010. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1981
Date Received
September 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code IDO

  • K864733 — LKB 2260 MACROTOME (January 5, 1987)
  • K863548 — ROTARY MICROTOME (September 19, 1986)
  • K843505 — LKB 2230 ROTARY ONE (November 30, 1984)
  • K812157 — LKB-BROMMA 2218 HISTORANGE MICROTOME (August 18, 1981)

FDA data resources