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Immunology

3,537 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT (K812328)Scripps-Miles, Inc.1981-09-08
GUINEA PIG COMPLEMENT VIRUS ANTIBODY (K812369)Dutchland Laboratories, Inc.1981-09-08
GELMAN IG-FIX KIT (K812253)Gelman Sciences, Inc.1981-09-01
CRITHIDNA ANTI-DNA TEST KIT (K812314)Antibodies, Inc.1981-09-01
KAPPA & LAMBDA BENCE JONES CONTROLS (K812327)Kallestad Laboratories, Inc.1981-09-01
IMMUNODIFFUSION BAND INTENSIFYING FLUID (K812194)American Scientific Products1981-08-31
ANTI-GM & ANTI-KM TYPING SERUMS (K812076)Biotest-Serum-Institut1981-08-12
ANTI-SKIN ANTIBODY TEST SYSTEM (K811261)Zeus Scientific, Inc.1981-08-12
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST (K811613)Kent Laboratories, Inc.1981-08-12
SPECTRO FEIRITIN (K812056)Ramco Laboratories, Inc.1981-08-12
THREE LEVEL CONTROL SERA (K810459)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-03
PHADEBAS IGG RAST TEST (K810694)Pharmacia, Inc.1981-07-23
LEECO FERRITIN-QUANT DIAG. TEST KIT (K811880)Leeco Diagnostics, Inc.1981-07-16
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME (K811721)Immulok, Inc.1981-07-16
KALLESTAD'S ENDOPLATE FACTOR B TEST (K811740)Kallestad Laboratories, Inc.1981-07-16
FERRITIN RIA KIT (K811804)Amersham Corp.1981-07-10
LIGHTNING DIALYZER (K810871)Clintox Laboratories, Inc.1981-07-10
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT (K811714)Scripps-Miles, Inc.1981-07-10
VENTRE/SEP IGE RIA TEST SET (K811559)Ventrex Laboratories, Inc.1981-07-10
AUTOPAK-12 FERRITIN KIT (K811808)Micromedic Systems1981-07-10
HELENA PLASMINOGEN QUIPLATE PROCEDURE (K811777)Helena Laboratories1981-07-02
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. (K811617)Kallestad Laboratories, Inc.1981-06-25
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG (K811545)Kallestad Laboratories, Inc.1981-06-24
KALLESTAD R QUANTIPLATE ALT. PATHWAY T. (K811445)Kallestad Laboratories, Inc.1981-06-24
SCRIPPSERA COMPLEMENT CONTROL SERA (K811433)Scripps-Miles, Inc.1981-06-16
BI-CRP LATEX TEST (K811374)Biologics Intl., Inc.1981-06-12
BI-RA SLIDE TEST (K811375)Biologics Intl., Inc.1981-06-12
CEA DESALTING DOLUMN SEPHADEX R (K811394)Immuno-Diagnostic Laboratories1981-06-12
TAN DEM* - IGE KIT (K802913)Hybritech, Inc.1981-05-29
AIM SYSTEM (FOR IGG) (K811126)Icl Scientific1981-05-08
AIM SYSTEM (FOR IGM) (K811124)Icl Scientific1981-05-08
AIM SYSTEM (FOR IGA) (K811125)Icl Scientific1981-05-08
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (K810984)Immuno-Products Industries1981-05-01
ANTISMOOTH MUSCLE ANTIBODY TEST SYS (K810983)Immuno-Products Industries1981-05-01
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (K810982)Immuno-Products Industries1981-05-01
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (K810985)Immuno-Products Industries1981-05-01
ANTI NDNA IMMUNOFLOURESCENT TEST SYS (K810981)Immuno-Products Industries1981-04-29
ANA TEST KIT (K811022)Immuno-Diagnostic Products, Inc.1981-04-23
AMICON ULTRAFILTRATION MEMBRANES CMII (K810810)Amicon, Inc.1981-04-17
KALLESTAD HEP-2 CELL LINE SUBSTRATE (K810863)Kallestad Laboratories, Inc.1981-04-14
CRP SLIDE (K810862)Syn-Kit, Inc.1981-04-08
SCRIPPSYSTEM C3 RID KIT (K810501)Scripps-Miles, Inc.1981-04-08
SCRIPPSYSTEM C4 RID KIT (K810502)Scripps-Miles, Inc.1981-04-08
QUANTIMUNE FERRITIN IRMA (K810799)Bio-Rad1981-04-03
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (K810625)Serono Laboratories, Inc.1981-03-27
PHADEZYM IGE PRIST TEST (K810507)Pharmacia, Inc.1981-03-20
RHEUMATOID FACTORS REFERENCE SERUM (K810404)Calbiochem-Behring Corp.1981-03-11
RHEUMATOID FACTOR REAGENT TEST KIT (K810306)Beckman Instruments, Inc.1981-03-11
PHADEZYM RAST TEST (K810462)Pharmacia, Inc.1981-03-11
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST (K810301)Immuno Concepts, Inc.1981-02-25
SLE ANTI-N-DNA LATEX TEST (K810226)Icl Scientific1981-02-09
IMMUNOLOGY CONTROL SERUM (K810056)Icl Scientific1981-02-09
SCRIPPSERA ANA REFERENCE CONTROL SERA (K810081)Scripps-Miles, Inc.1981-02-09
SCRIPPSERA THEUMATOID FACTOR REFER. CNTL (K810221)Scripps-Miles, Inc.1981-02-09
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT (K810141)Scripps-Miles, Inc.1981-02-09
K/K (ASMA/ANA) UNIVERSAL BIOPAK (K802299)Bioware Products1981-01-29
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA (K803274)Icl Scientific1981-01-26
ANA-IFA TEST SYSTEM (K803276)Immuno Concepts, Inc.1981-01-26
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (K803272)Icl Scientific1981-01-26
AIP SYSTEM-METHOD FOR IGM (K803251)Icl Scientific1981-01-26
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (K802610)Hyland Therapeutic Div., Travenol Laboratories1981-01-05
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. (K802448)Syn-Kit, Inc.1981-01-05
TEST KIT FOR DETECTION OF ANTINUCLEAR (K802527)Bartels & Stout, Inc.1981-01-05
RHEUMATOID FACTOR TEST SYSTEMS (K802688)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-18
PHADEBAS RAST TEST (K802556)Pharmacia, Inc.1980-12-02
T/K (ATA/AMA) UNIVERSAL BIOPAK (K802308)Bioware Products1980-12-01
GOAT ANTI-HUMAN IGM (K802177)Protos Laboratories1980-10-31
GOAT ANTI-HUMAN COMPLEMENT C4 (K802196)Protos Laboratories1980-10-31
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC (K802257)Protos Laboratories1980-10-31
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. (K802284)Kallestad Laboratories, Inc.1980-10-23
ANTISERA TO HUMAN FREE KAPPA CHAINS (K802283)Kallestad Laboratories, Inc.1980-10-23
ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (K802404)Ortho Diagnostics, Inc.1980-10-23
ANTI-DS/N-DNA TEST KIT (K801960)Immuno-Diagnostic Products, Inc.1980-10-10
RF-II TEST KIT (K801961)Immuno-Diagnostic Products, Inc.1980-10-10
BCM-302 COLLIMATING CONE & COMPENSATIN (K801949)B C Medical , Ltd.1980-10-03
CLINETICS PCA COLUMN (K801306)Clinetics Corp.1980-09-26
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (K801909)J.T. Baker Chemical Co.1980-09-26
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (K792377)Environmental Chemical Specialties1980-09-26
NORDICLAB FERRITIN IRMA TEST (K801989)Nordiclab Intl.1980-09-16
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (K801669)J.T. Baker Chemical Co.1980-09-16
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (K801662)J.T. Baker Chemical Co.1980-09-16
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (K801661)J.T. Baker Chemical Co.1980-09-16
FERRIZYME FERRITIN ENZYME IMMUNOASSAY (K801676)Abbott Laboratories1980-08-20
FERRITIN RIA KIT (K801580)Diagnostic Products Corp.1980-08-13
DISC 120 TRANSPORTER (K801391)Travenol Laboratories, S.A.1980-07-14
HEMOPEXIN NEPHELOMETRIC ASSAY (K801432)J.T. Baker Chemical Co.1980-07-08
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (K801434)J.T. Baker Chemical Co.1980-07-08
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K801433)J.T. Baker Chemical Co.1980-07-08
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K801361)J.T. Baker Chemical Co.1980-06-30
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K801363)J.T. Baker Chemical Co.1980-06-30
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA (K801282)J.T. Baker Chemical Co.1980-06-30
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY (K801283)J.T. Baker Chemical Co.1980-06-30
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI (K801281)J.T. Baker Chemical Co.1980-06-20
AUTOFLUOR SYSTEM (K800698)California Immuno Diagnostic, Inc.1980-05-28
125I-IGE RADIOIMMUNOASSAY KIT (K801019)Bio-Ria1980-05-20
ANATON (K801046)Armkel, LLC1980-05-14
IMMUNOGLOBULIN E TEST KIT (K800995)Calbiochem-Behring Corp.1980-05-14
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. (K800897)Icl Scientific1980-05-08
CORDIA N (K800991)Cordis Corp.1980-05-08
CORDIA NP (K800992)Cordis Corp.1980-05-08
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