510(k) K844683

IMAGEN CHLAMYDIA TEST by Boots-Celltech Diagnostics, Inc. — Product Code IWP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 6, 1985
Date Received: November 30, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radiographic Protective Glove
Device Class: Class I
Regulation Number: 892.6500
Review Panel: RA
Submission Type

A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

Other clearances by Boots-Celltech Diagnostics, Inc.

K871877 — IDEIA HERPES SIMPLEX VIRUS TEST (November 17, 1989)
K880799 — MODIFIED IDEIA CHLAMYDIA TEST (December 8, 1988)
K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (April 18, 1988)
K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (March 24, 1988)
K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI (February 24, 1988)
K872843 — OVEIA (TM) DUAL ANALYTE (February 2, 1988)
K873625 — CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (October 20, 1987)
K872056 — MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (June 15, 1987)
K870602 — IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (May 8, 1987)
K864998 — IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (April 20, 1987)

510(k) K844683

Clearance Details

Device Classification

Other clearances by Boots-Celltech Diagnostics, Inc.

Other clearances for product code IWP