Atlas FDA

PHADEBACT CSF TEST 20

FDA 510(k) clearance K822810 · decided 1982-12-30

Clearance details

K-number
K822810
Device name
PHADEBACT CSF TEST 20
Applicant
Pharmacia, Inc.
Decision
Substantially Equivalent
Date received
1982-09-20
Decision date
1982-12-30
Days to decision
101 days
Clearance type
Traditional
Product code
GTJ
Device class
2
Regulation number
866.3390
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Walker, MI, 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
DIRECTIGEN MENINGITIS COMBO TEST (K952791)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-05-30
DIRECTIGEN MENINGITIS COMBO TEST KIT (K915330)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-23
SLIDEX MENINGITE-KIT 5 (K910210)Vitek Systems, Inc.1991-08-12
BACTIGEN(R) N. MENINGITIDIS (K885004)Armkel, LLC1989-02-07
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (K870089)Microscan Div. Baxter Healthcare Corp.1987-03-17
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (K854851)Wellcome Diagnostics1986-02-04
WELLCOGEN BACTERIAL ANTIGEN KIT (K854852)Wellcome Diagnostics1986-02-04
PHADEBACT CSF TEST (K844999)Pharmacia, Inc.1985-10-17
WILLCOGEN MENINGITIDIS KIT ZL25 (K851691)Wellcome Diagnostics1985-06-10
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (K844762)Wellcome Diagnostics1985-06-04
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (K844407)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-25
BACTIGEN - N.MENNINIGITIDIS TEST (K841907)Armkel, LLC1984-07-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MODELS 011 & 011B IRIDOCAPSULAR IOLS (P810042)Pharmacia, Inc.1982-12-15