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Hyland Therapeutic Div., Travenol Laboratories · Predicate Candidate Screening

44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

44 daysmedian FDA review time

105 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days
K820835	ALUMINA SILICA-ACTIVATED PARTIAL THROM	Hyland Therapeutic Div., Travenol Laboratories	1982-04-26	31
K820192	HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM	Hyland Therapeutic Div., Travenol Laboratories	1982-03-11	45
K812220	NEPHELOMETRIC SOLID TURBIDITY STANDARD	Hyland Therapeutic Div., Travenol Laboratories	1981-08-18	12
K810078	Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S	Hyland Therapeutic Div., Travenol Laboratories	1981-02-02	20
K810077	OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.	Hyland Therapeutic Div., Travenol Laboratories	1981-01-28	15
K802610	ALERT A,HDL-APOLIPOROTEIN A, TEST KIT	Hyland Therapeutic Div., Travenol Laboratories	1981-01-05	76
K791113	LOW IONIC STRENGTH SOLUTION (LISS)	Hyland Therapeutic Div., Travenol Laboratories	1979-06-28	13
K790249	TEST CELLS	Hyland Therapeutic Div., Travenol Laboratories	1979-05-16	97
K781225	GLOBULIN TEST, HUMAN THYROXINE BINDING	Hyland Therapeutic Div., Travenol Laboratories	1978-08-31	44
K780962	AUTOMATED ENZYME	Hyland Therapeutic Div., Travenol Laboratories	1978-07-27	45
K780785	DILUTOR TRANSPORTER	Hyland Therapeutic Div., Travenol Laboratories	1978-06-14	33
K780753	LAS-R HUMAN IGE TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-06-06	29
K780729	LAS-R HUMAN COMPLEMENT CLQ TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-05-18	16
K780203	THROMBOPLASTIN DRIED	Hyland Therapeutic Div., Travenol Laboratories	1978-03-27	48
K780335	LAS-R HUMAN C1 ESTERASE INHIBITOR TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-03-22	22
K780204	CHEMISTRY CONTROL & REFERENCE SERUMS	Hyland Therapeutic Div., Travenol Laboratories	1978-03-03	24
K772327	LAS-R HUMAN IGD TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-02-28	69
K772328	LAS-R HUMAN ANTITHROMBIN III TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-02-03	44
K772329	LAS-R HUMAN PREALBUMIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-02-03	44
K772084	LAS-R HUMAN C3 PROACTIVATOR TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-01-24	81
K772085	LAS-R HUMAN PLASMINOGEN TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-01-24	81
K771445	HERPES I.D. TM TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-12-14	135
K771795	LAS-R CERULOPLASMIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-11-14	52
K771700	TMA BICARBONATE/GLYCEROL DILUENT	Hyland Therapeutic Div., Travenol Laboratories	1977-11-11	65
K771879	GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID	Hyland Therapeutic Div., Travenol Laboratories	1977-10-19	15
K771912	LAS-R BETA LIPOPROTEIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-10-19	8
K771780	LAS-R TM	Hyland Therapeutic Div., Travenol Laboratories	1977-10-04	11
K771535	LAS-R HUMAN CRP TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-09-02	23
K771552	LAS-R RHEUMATOID FACTOR TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-08-30	18
K771446	TRANSPORTEO MODULE	Hyland Therapeutic Div., Travenol Laboratories	1977-08-10	9
K771226	LAS-R TEST PROGRAM	Hyland Therapeutic Div., Travenol Laboratories	1977-07-21	20
K771044	TMA BICARBONATE DILUENT	Hyland Therapeutic Div., Travenol Laboratories	1977-07-15	35
K770547	LAS-R TM HUMAN COMPLEMENT C4 TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-05-03	43
K770010	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A	Hyland Therapeutic Div., Travenol Laboratories	1977-04-18	105
K770011	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B	Hyland Therapeutic Div., Travenol Laboratories	1977-04-18	105
K770012	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C	Hyland Therapeutic Div., Travenol Laboratories	1977-04-18	105
K770548	IMMUNOPLATE III RADIO IMMUNODIFFUSION	Hyland Therapeutic Div., Travenol Laboratories	1977-04-15	25
K761008	LYMPHOCYTE TYPING, NEGATIVE CONTROL	Hyland Therapeutic Div., Travenol Laboratories	1977-04-06	155
K761009	LYMPHOCYTE TYPING, POSITIVE CONTROL	Hyland Therapeutic Div., Travenol Laboratories	1977-04-06	155
K760918	HEPARIN CONTROL PLASMA	Hyland Therapeutic Div., Travenol Laboratories	1977-01-10	74
K760917	LAS-R HUMAN HAPTOGLOBIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1976-12-30	63
K760916	LAS-R HUMAN ALPHA, ANTITRYPSIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1976-11-16	19
K760818	TRIS BICARBONATE DILUENT	Hyland Therapeutic Div., Travenol Laboratories	1976-11-05	24
K760499	REAGENT, PARTIAL THROMBOPLASTIN	Hyland Therapeutic Div., Travenol Laboratories	1976-10-29	67

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda