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Immunology

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

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RecordFirmDate
FERRITIN KIT (K781844)Ria Products, Inc.1979-01-10
FIAX TEST KIT (K782041)Idt, A Division of Whittaker M.A. Bioproducts1979-01-03
PLASMINOGEN ASSAY (K781478)Dade, Baxter Travenol Diagnostics, Inc.1978-11-15
NEPHELRATE ANTISERUMS C3C (K781653)Antibodies, Inc.1978-11-08
NEPHELRATE ANTISERUMS 1GA (K781655)Antibodies, Inc.1978-11-08
NEPHELRATE ANTIPERUMS LGM (K781654)Antibodies, Inc.1978-11-08
NEPHELRATE ANTISERUMS, IGG (K781656)Antibodies, Inc.1978-11-08
RIA SYSTEM FOR HUMAN FE-RITIN (K781527)Calbiochem-Behring Corp.1978-10-03
FLUORESCENT ANTI-NATIVE DNA TEST (K780899)Kallestad Laboratories, Inc.1978-09-07
IMMUNOCHEMISTRY SYS. MANUAL MODE (K781006)Beckman Instruments, Inc.1978-08-31
ICS NORMAL CONTROL SERUM (K781355)Beckman Instruments, Inc.1978-08-31
RID SYSTEM-(ACP) TEST (K781408)Icl Scientific1978-08-21
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) (K781017)Icl Scientific1978-08-14
ANTI-HUMAN CIQ SERUM (K781022)Icl Scientific1978-08-14
ANTI-HUMAN LDL SERUM (K781015)Icl Scientific1978-08-14
C3PA (GBG) PROPERDIN FACTOR B (K781016)Icl Scientific1978-08-14
ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU (K781023)Icl Scientific1978-08-14
CERUOPLASMIN SERUM ANTI-HUMAN (K781024)Icl Scientific1978-08-14
SECOND ANTIBODY (K781070)Pcl-Ria, Inc.1978-08-10
KAPPA SERUM (FREE) ANTI-HUMAN (K781027)Icl Scientific1978-07-27
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN (K781028)Icl Scientific1978-07-27
LAMBDA SERUM (FREE) ANTI-HUMAN (K781025)Icl Scientific1978-07-27
ANTI-HUMAN LAMBDA SERUM (K781220)Icl Scientific1978-07-27
KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (K780982)Cis Radiopharmaceuticals, Inc.1978-06-22
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM (K780913)Beckman Instruments, Inc.1978-06-22
THYMUNE-M (K780873)Burroughs Wellcome Co.1978-06-14
THYMUNE-T (K780874)Burroughs Wellcome Co.1978-06-14
LAS-R HUMAN IGE TEST (K780753)Hyland Therapeutic Div., Travenol Laboratories1978-06-06
LAS-R HUMAN COMPLEMENT CLQ TEST (K780729)Hyland Therapeutic Div., Travenol Laboratories1978-05-18
NEIA-FERRITIN ENZYMEIMMUNOASSAY (K780490)New England Immunology Assoc.1978-04-10
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST (K780335)Hyland Therapeutic Div., Travenol Laboratories1978-03-22
RID SYSTEM-HUMAN C-REACTIVE PROTEIN (K780325)Icl Scientific1978-03-17
LAS-R HUMAN IGD TEST (K772327)Hyland Therapeutic Div., Travenol Laboratories1978-02-28
HEMOPEXIN NEPHELOMETRIC ASSAYS (K780250)Kallestad Laboratories, Inc.1978-02-28
TEST SYS. FOR NDNA ANTIBODY DETERM. (K780178)Zeus Scientific, Inc.1978-02-13
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER (K780161)Zeus Scientific, Inc.1978-02-07
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (K772075)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (K772076)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (K772077)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (K772079)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-COMP. 3 (K772073)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (K772074)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (K772078)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (K772080)Gelman Instrument Co.1978-02-03
LAS-R HUMAN PREALBUMIN TEST (K772329)Hyland Therapeutic Div., Travenol Laboratories1978-02-03
LAS-R HUMAN PLASMINOGEN TEST (K772085)Hyland Therapeutic Div., Travenol Laboratories1978-01-24
LAS-R HUMAN C3 PROACTIVATOR TEST (K772084)Hyland Therapeutic Div., Travenol Laboratories1978-01-24
FIAX TEST FOR ANTI-RUBELLA ANTIBODY (K772219)Idt, A Division of Whittaker M.A. Bioproducts1978-01-20
CERULOPLASMIN NEPHEL. ASSAY (K772255)Kallestad Laboratories, Inc.1978-01-05
FLUORESCEIN CONJUG. FRACT. MONO. ANTI. (K772345)Kallestad Laboratories, Inc.1978-01-05
HEMAGGLUTINATION INHIBITION TEST (K772095)Miles Laboratories, Inc.1978-01-05
IMMUNOGLOBULIN A NEPHEL. ASSAY (K772251)Kallestad Laboratories, Inc.1977-12-22
IMMUNOGLOBULIN M NEPHEL. ASSAY (K772254)Kallestad Laboratories, Inc.1977-12-22
HAPTOGLOBIN NEPHELOMETRIC ASSAY (K772245)Kallestad Laboratories, Inc.1977-12-22
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY (K772250)Kallestad Laboratories, Inc.1977-12-22
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY (K772246)Kallestad Laboratories, Inc.1977-12-22
IMMUNOGLOBULIN G NEPHEL. ASSAY (K772252)Kallestad Laboratories, Inc.1977-12-22
TRANSFERRIN NEPHELOMETRIC ASSAY (K772253)Kallestad Laboratories, Inc.1977-12-22
COMPLEMENT C4 NEPHELOMETRIC ASSAY (K772247)Kallestad Laboratories, Inc.1977-12-22
FIAX C4 ASSAY (K772114)Idt, A Division of Whittaker M.A. Bioproducts1977-11-30
FLUORESCEIN CONJUGATED (K772128)Kallestad Laboratories, Inc.1977-11-22
LAS-R CERULOPLASMIN TEST (K771795)Hyland Therapeutic Div., Travenol Laboratories1977-11-14
HUMAN C4 COMPLEMENT CONTROL SERUM (K772004)G.D. Searle and Co.1977-11-03
HUMAN REFERENCE SERUM C4 COMPLEMENT (K772003)G.D. Searle and Co.1977-11-03
AFT SYSTEM (K771993)Calbiochem1977-11-02
PLATES FOR HUMAN C4 COMPLEMENT (K772002)G.D. Searle and Co.1977-11-02
QUANTROLS RF (K771940)Organon, Inc.1977-11-02
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID (K771879)Hyland Therapeutic Div., Travenol Laboratories1977-10-19
LAS-R BETA LIPOPROTEIN TEST (K771912)Hyland Therapeutic Div., Travenol Laboratories1977-10-19
IFA ANTI-NDNA (K771376)Electro-Nucleonics Laboratories, Inc.1977-10-18
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (K771812)Gelman Instrument Co.1977-10-18
QUAN. COLOR. DETER. OF SERUM ALBUMIN (K771771)Stanbio Laboratory1977-10-07
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM (K771768)G.D. Searle and Co.1977-10-07
LAS-R TM (K771780)Hyland Therapeutic Div., Travenol Laboratories1977-10-04
IMMOCHEMISTRY SYSTEM (K771603)Beckman Instruments, Inc.1977-09-15
LAS-R HUMAN CRP TEST (K771535)Hyland Therapeutic Div., Travenol Laboratories1977-09-02
PHADEBAS RAST PENICLLOYL G/V TEST (K771578)Pharmacia, Inc.1977-09-02
RHEUMANOSTICON R (K771410)Organon, Inc.1977-09-02
FLUORESCENT ANTI. ANTI-HUMAN C3 (K771583)Burroughs Wellcome Co.1977-09-02
LAS-R RHEUMATOID FACTOR TEST (K771552)Hyland Therapeutic Div., Travenol Laboratories1977-08-30
MONOSTICON TEST (K771397)Organon, Inc.1977-08-22
ANTI-MITOCHONDRIAL (K771155)Meloy Laboratories, Inc.1977-08-04
ANTISERA TO HUMAN FAB FRAGMENT (K771242)Kent Laboratories, Inc.1977-08-03
ANTISERA TO HUMAN FAB FRAGMENT (K771243)Kent Laboratories, Inc.1977-08-03
LAS-R TEST PROGRAM (K771226)Hyland Therapeutic Div., Travenol Laboratories1977-07-21
RID PLATES & INTENSI. FOR HUMAN IGE ETC (K771238)G.D. Searle and Co.1977-07-15
RHODAMINE-CONJUGATED ANTISERUM (K771144)Kent Laboratories, Inc.1977-07-14
CRP-WELLCOTEST (K771139)Burroughs Wellcome Co.1977-07-14
GOAT ANTISERUM COMPLEMENT C3 NEPHEL. (K770964)Kallestad Laboratories, Inc.1977-06-24
ANA TEST (K771064)Gull Laboratories, Inc.1977-06-24
GOAT ANTISERUM IGA NEPHELOMETRIC (K770962)Kallestad Laboratories, Inc.1977-06-24
GOAT ANTISERUM IGM NEPHELOMHTRIC (K770963)Kallestad Laboratories, Inc.1977-06-24
GOAT ANTISERUM IGG NEPHELOMETRIC (K770961)Kallestad Laboratories, Inc.1977-06-24
IN VITRO FERRITIN RIA TEST (K770702)Clinical Assays, Inc.1977-06-17
RABBIT COMPLEMENT (K770866)Cedarlake Labs , Ltd.1977-06-03
LAS-R TM HUMAN COMPLEMENT C4 TEST (K770547)Hyland Therapeutic Div., Travenol Laboratories1977-05-03
RHODAMINE-CONJUGATED ANTISERUM (K770669)Kent Laboratories, Inc.1977-04-28
FLOR. CONJUG. HUMAN FAB FRAGMENT (K770670)Kent Laboratories, Inc.1977-04-28
FLUORESCEIN CONJUGATED ANTISERUM (K770668)Kent Laboratories, Inc.1977-04-28
DASP TM ANTI-RABBIT (K770597)Organon, Inc.1977-04-28
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