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510(k) K883411

PG-NUMERIC(TM) by Isolab, Inc. — Product Code JHF

K883411 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "PG-NUMERIC(TM)". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code JHF (Colorimetric Method, Lecithin/Sphingomyelin Ratio), a Class II device regulated under 21 CFR 862.1455. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Lecithin/Sphingomyelin Ratio
Device Class
Class II
Regulation Number
862.1455
Review Panel
CH
Submission Type

Other clearances by Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (September 21, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)

Other clearances for product code JHF

  • K940817 — TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II (February 8, 1995)

FDA data resources