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510(k) K801426

TISSUE-TEK III MICROJECT DISP. BLADE SYS by Miles Laboratories, Inc. — Product Code IDL

K801426 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "TISSUE-TEK III MICROJECT DISP. BLADE SYS". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code IDL (Microtome, Accessories), 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
July 28, 1980
Date Received
June 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtome, Accessories
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 IDL

  • K863616 — KNIFE MAKER (September 25, 1986)
  • K831921 — DISPOSABLE MICROTOME BLADES (July 29, 1983)
  • K831308 — DISPOSABLE MICROTOME BLADE (May 16, 1983)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)

FDA data resources