Kova 87128Q

• FDA 510(k) K843565 decided 5 Oct 1984 Active
• FDA GUDID UDI-DI 00855617006422 listed 31 Jul 2020 Listed

1. 5 Oct 1984 Cleared FDA 510(k) K843565
2. 31 Jul 2020 Listed FDA GUDID 00855617006422

Trade name

Kova

Generic name

Urine sediment IVD, control

Model / Ref / Catalog

87128Q

Primary DI / UDI-DI

00855617006422

510(k) Number

K843565 ↗

FDA product code

JJW

GMDN term

Urine sediment IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Urine sediment IVD, control

Other devices filed under FDA product code JJW (Urinalysis Controls (Assayed And Unassayed)).

• QwikCheck Beads Proficiency and Training Kit by M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• PRODUCT #K3002 KETOTROL-N(URINE CONTROL) by Sigma Chemical Co.
• AUTION CHECK PLUS by QUANTIMETRIX CORP.
• J&S MEDICAL SENTRY URINE DIPSTICK CONTROL by J.S. Medical Assoc.
• URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 by Bio-Rad
• DADE ASSAYED URINALYSIS CONTROL by Medical Analysis Systems, Inc.
• CHEMSTRIP CONTROL by Boehringer Mannheim Corp.
• KOVA TROL I, II, III HUMAN URINE-DRIED by Icl Scientific
• MAS Urinalysis Liquid Urinalysis Control 1 024222 by Microgenics Corporation
• QUANTITATIVE CONTROL URINE II (HUMAN) by Environmental Chemical Specialties

• Kova 87426

  Class I

  FDA 510(k) K843565 Active Cleared 5 Oct 1984 GUDID on market

• Kova 87528

  Class I

  FDA 510(k) K843565 Active Cleared 5 Oct 1984 GUDID on market

• Kova 87155

  Class I

  GUDID on market

• Kova 87158E

  Class I

  GUDID on market

See all devices from Kova International Inc →