Atlas FDA

BION HSV1-G OR HSV2-G TEST SYSTEM

FDA 510(k) clearance K881261 · decided 1988-06-07

Clearance details

K-number
K881261
Device name
BION HSV1-G OR HSV2-G TEST SYSTEM
Applicant
Bion Ent., Ltd.
Decision
Substantially Equivalent
Date received
1988-03-24
Decision date
1988-06-07
Days to decision
75 days
Clearance type
Traditional
Product code
GQO
Device class
2
Regulation number
866.3305
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Park Ridge, IL, 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
VIRGO HSV-2 IGG ELISA (K883281)Electro-Nucleonics, Inc.1989-03-10
VIRGO HSV-1 IGG ELISA (K883282)Electro-Nucleonics, Inc.1989-03-10
THE DDI SERODOT HERPES IGG TEST KIT (K875366)Disease Detection International, Inc.1988-05-23
VIROGEN HSV ANTIBODY TEST (K871426)Armkel, LLC1987-10-15
THE GOLDEN QUAD TEST (HSV) (K861120)Microbiological Research Corp.1987-02-02
VISIBLE-HERPES TM TEST SYSTEM (K854712)Isolab, Inc.1986-05-20
HSVI - IGG ELISA-KIT (K852782)Clinical Sciences, Inc.1986-01-21
HSV2 - IGG ELISA-KIT (K852781)Clinical Sciences, Inc.1986-01-21
AMIZYME-HSV TYPES 1 & 2 TEST KITS (K842531)Amico Lab, Inc.1985-12-06
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (K842663)Amico Lab, Inc.1985-12-06
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (K852931)Microbix Biosystems, Inc.1985-11-12
ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245)Behring Diagnostics, Inc.1985-11-05

Recalls involving this device

RecordFirmDate
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a c recall (Z-1477-2013)Bion Enterprises Ltd2013-06-05