Product Code: KIS FDA class 1 21 CFR 864.2800

Sera, Animal And Human

Hematology

Animal and Human Sera are biological reagents derived from the serum component of animal or human blood, used in laboratory cell culture systems to supply growth factors, nutrients, and proteins that support cell viability and proliferation in in vitro diagnostic and research applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIS, regulated under 21 CFR 864.2800, within the Hematology medical specialty.

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FEI Numbers

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Basic Information

Product Code: KIS
Device Class: FDA class 1
Regulation Number: 864.2800
Medical Specialty: Hematology
Review Panel: PA
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K881287	ANIMAL AND HUMAN SERA	Apr 05, 1988	Substantially Equivalent	Cell Culture Laboratories
K880471	BOVINE CALF SERUM SUPPLEMENTED #A-2159	Apr 04, 1988	Substantially Equivalent	Hyclone Laboratories, Inc.
K880470	BOVINE CALF SERUM CATALOG #A-2119	Apr 01, 1988	Substantially Equivalent	Hyclone Laboratories, Inc.
K872847	SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT	Aug 10, 1987	Substantially Equivalent	Candace Lane Corp.
K870580	MLC NORMAL SERUM	Apr 08, 1987	Substantially Equivalent	Rjo Biologicals, Inc.
K870938	FETAL BOVINE SERUM	Mar 31, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870469	DEFINED EQUINE SERUM #A-3311	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870468	ADULT BOVINE SERUM	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870467	DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870466	DEFINED CALF BOVINE SERUM #A-2111	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870465	6/40 FETAL BOVINE SERUM #A-1110	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870464	CHARACTERIZED FETAL BOVINE SERUM #A-1115	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K870463	DEFINED FETAL BOVINE SERUM #A-1111	Mar 24, 1987	Substantially Equivalent	Hyclone Laboratories, Inc.
K861817	HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861816	MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861815	BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861814	RHESUS MONKEY SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861813	HUMAN AB SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861812	HUMAN SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861811	MOUSE SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861810	CHICKEN SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861809	LAMB SERUM - STERILE FILTERED	May 20, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K860762	GAMMA-FREE HORSE SERUM	Mar 10, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K860752	GOAT SERUM (29-391-54)	Mar 10, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K853803	FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB	Oct 15, 1985	Substantially Equivalent	Z.L. Bocknek Laboratories, Inc.
K843629	FETAL BOVINE SERUM, F4884 STERILE GROWT	Oct 01, 1984	Substantially Equivalent	Sigma Chemical Co.
K833463	CLEX	Nov 21, 1983	Substantially Equivalent	Dextran Products, Ltd.
K812386	FETAL BOVINE SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812385	NATAL CALF (BOVINE) SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812384	NEWBORN CALF SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812383	CALF (BOVINE) SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812382	DONOR CALF (BOVINE-SERUM) - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812381	DONOR HORSE SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812380	RABBIT SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812379	GUINEA PIG SERUM - STERILE	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812329	ZETA-SERA D	Sep 01, 1981	Substantially Equivalent	Amf Biological and Diagnostics Co.
K810775	GOAT SERUM-STERILE	May 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K810874	FETAL CALF SERUM	Apr 23, 1981	Substantially Equivalent	Tissue Culture Biologicals
K810904	BOVINE CALF SERUM	Apr 14, 1981	Substantially Equivalent	Biolabs, Inc.
K810903	NEWBORN BOVINE SERUM	Apr 14, 1981	Substantially Equivalent	Biolabs, Inc.
K810478	ANIMAL SERUM PRODUCTS	Apr 08, 1981	Substantially Equivalent	Animal Health Laboratories, Inc.
K810268	NORMLCERA	Mar 06, 1981	Substantially Equivalent	Medical Specialties Laboratories
K802418	FETAL BOVINE SERUM	Oct 31, 1980	Substantially Equivalent	S&S Biologicals
K800781	FETAL BOVINE SERUM	Apr 21, 1980	Substantially Equivalent	Biolabs, Inc.
K780009	GUINEA PIG WHOLE SERUM	Jan 20, 1978	Substantially Equivalent	Northeast Biomedical Labs., Inc.