Atlas FDA

POCKIT HSV 2 RAPID TEST

FDA 510(k) clearance K983886 · decided 1999-08-19

Clearance details

K-number
K983886
Device name
POCKIT HSV 2 RAPID TEST
Applicant
Diagnology , Ltd.
Decision
Substantially Equivalent
Date received
1998-11-02
Decision date
1999-08-19
Days to decision
290 days
Clearance type
Traditional
Product code
LGC
Device class
2
Regulation number
866.3305
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Cadwell, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HERPES GROUP IGG (K033059)Trinity Biotech, Inc.2003-11-26
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THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K992166)Zeus Scientific, Inc.1999-09-03
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (K984346)Meridian Diagnostics, Inc.1999-06-25
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM (K983656)Zeus Scientific, Inc.1999-03-18
HSV 1+2 IGG ELISA TEST (K983541)Gull Laboratories, Inc.1999-02-26
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (K981306)Diamedix Corp.1998-09-29
HERPES GROUP IGG ELISA TEST SYSTEM (K963645)Armkel, LLC1997-02-04
SERAQUEST HSV IGG (K963282)Quest Intl., Inc.1997-01-22
IMMULITE HERPES I AND II IGG (K950670)Diagnostic Products Corp.1996-06-21

Recalls involving this device

RecordFirmDate
biokitHSV-2 Rapid Test, REF: 300028001 recall (Z-1021-2023)Biokit, S.A.2023-01-26
Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic tes recall (Z-1970-2010)Biokit U.S.A. Inc.2010-07-08
Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test f recall (Z-1971-2010)Biokit U.S.A. Inc.2010-07-08