Remel Cleveland, A Division of Remel Inc.

Matched from indexed company URL: Remel Inc.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1530126	1000515493	Remel Cleveland, A Division of Remel Inc.	1	Y	2026-01-01	1 Thermo Fisher Way Oakwood Village OH US 44146
1924669	1924669	REMEL, INC.	1	Y	2026-01-01	12076 Santa Fe Trail Dr LENEXA KS US 66215
1031428	1031428	REMEL ATLANTA, A DIV. OF REMEL, INC.	1	N	2020-04-25	2797 Peterson Pl NORCROSS GA US 30071

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
7644	1739318087	K990842	SAS ROTA TEST	LIQ	1999-08-09
7644	1048930494	K972359	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	JSO	1997-08-28
7644	1547265486	K965152	A.C.T. II	JSM	1997-01-22
7644	1754030012	K965149	A.C.T. I	JSM	1997-01-22
7644	1193463446	K964315	REMEL STAPH LATEX KIT	JWX	1997-02-07
38116	1193463446	K964315	REMEL STAPH LATEX KIT	JWX	1997-02-07
7644	1591888077	K962966	IDS RAPID CB PLUS SYSTEM	JTO	1996-10-08
38116	1591888077	K962966	IDS RAPID CB PLUS SYSTEM	JTO	1996-10-08
7644	1969548421	K961046	10B ARGININE BROTH	JSM	1996-09-18
7644	1639941799	K960997	STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM	LIO	1996-04-03
7644	1883419476	K960313	MUELLER HINTON AGAR WITH 2% NACI	JTZ	1996-03-25
7644	1947545057	K960095	BACTIDROP CALCOFLUOR WHITE	JTS	1996-03-19
7644	1778195024	K960090	CALCOFLUOR WHITE STAIN KIT	JTS	1996-03-19
7644	1913764224	K954986	GC BASE W/ 1% GCHI	JTY	1996-02-16
7644	1881172625	K944847	KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM	JSL	1995-02-16
7644	1305576153	K943621	RAPID YEAST PLUS SYSTEM	JXB	1995-01-27
38116	1305576153	K943621	RAPID YEAST PLUS SYSTEM	JXB	1995-01-27
7644	1937591732	K943499	KULTSURE STARSWAB(M240), MODIFICATION	JSM	1994-11-30
7644	1343071083	K941579	MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)	JSM	1994-10-21
7644	1473884112	K941444	BHI AGAR WITH VANCOMYCIN	JSO	1994-09-19
7644	1240100051	K941443	SYNERGY QUAD	JSO	1994-09-19
7644	1802887496	K936021	BACTICARD STREP	JTO	1994-05-20
38116	1802887496	K936021	BACTICARD STREP	JTO	1994-05-20
7644	1133934102	K935124	BACTICARD CANDIDA	JXB	1994-02-25
38116	1133934102	K935124	BACTICARD CANDIDA	JXB	1994-02-25
7644	1490561345	K934986	BACTICARD E. COLI	JTO	1994-02-23
38116	1490561345	K934986	BACTICARD E. COLI	JTO	1994-02-23
7644	1842342920	K933457	RIM E.COLI 0157:H7 LATEX TEST	GNA	1994-04-20
38116	1842342920	K933457	RIM E.COLI 0157:H7 LATEX TEST	GNA	1994-04-20
7644	1039457320	K931383	ZINC PVA	LIO	1993-06-15
7644	1822990341	K930418	CRYPTO-LEX SYSTEM	GMD	1994-02-17
38116	1822990341	K930418	CRYPTO-LEX SYSTEM	GMD	1994-02-17
7644	1252112496	K923827	LAP DISK	JTO	1992-09-28
38116	1252112496	K923827	LAP DISK	JTO	1992-09-28
7644	1694385025	K923700	INDOXYL ACETATE DISK	JTO	1992-10-05
38116	1694385025	K923700	INDOXYL ACETATE DISK	JTO	1992-10-05
7644	1787704886	K923566	NIZYME TEST KIT	JSX	1992-11-02
38116	1787704886	K923566	NIZYME TEST KIT	JSX	1992-11-02
7644	1519682398	K921556	MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM	LJZ	1992-06-29
38116	1519682398	K921556	MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM	LJZ	1992-06-29
7644	1895999506	K921472	M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)	JSM	1992-05-06
7644	1057729695	K920976	BACTIDROP INDIA INK	JTS	1992-06-09
7644	1136368526	K920974	BACTIDROP ACRIDINE ORANGE	JFO	1992-06-19
7644	1750056136	K920973	BACTIDROP INDOLE (ERLICH'S)	JTO	1992-06-19
7644	1253293869	K920972	BACTIDROP PYR	JTO	1992-05-22
7644	1939429602	K920971	BACTIDROP NINHYDRIN	JTO	1992-05-22
7644	1108116601	K920970	BACTIDROP KOH (10%)	JTS	1992-06-09
7644	1491758063	K920257	NIACIN CONTROL DISKS	JTO	1992-04-22
38116	1491758063	K920257	NIACIN CONTROL DISKS	JTO	1992-04-22
7644	1295329819	K913011	BACTIDROP(TM) NITRATE A	JTO	1991-09-19
7644	1745363173	K913010	BACTIDROP (TM) NITRATE B	JTO	1991-09-19
7644	1061657086	K913009	BACTIDROP(TM) INDOLE (KOVACS)	JTO	1991-09-18
7644	1302713725	K913008	BACTIDROP(TM) OXIDASE	JTO	1991-09-23
7644	1452478536	K913007	BACTIDROP(TM) VOGES-PROSKAUER B	JTO	1991-09-23
7644	1236866387	K913006	BACTIDROP(TM) DOBELL & O'CONNOR IODINE	JTO	1991-09-23
7644	1713277131	K913005	BACTIDROP(TM) LACTOPHENOL ANILINE BLUE	JIO	1991-09-16
7644	1634120824	K913004	BACTIDROP(TM) SPOT INDOLE	JTO	1991-09-18
7644	1442860924	K913003	BACTIDROP(TM) VOGES-PROSKAUER A	JTO	1991-09-23
7644	1639858522	K913002	BACTIDROP(TM) FERRIC CHLORIDE (10%)	JTO	1991-09-23
7644	1953728524	K913001	BACTIDROP(TM) DESOXYCHOLATE (10%)	JTO	1991-09-18
7644	1762599827	K912832	BACTI-SWAB(TM) NPG	LIO	1991-08-22
7644	1471733840	K912831	BACTI-SWAB(TM) II	LIO	1991-07-30
7644	2050170264	K911419	SENSITITRE ARIS MODULE	LRG	1992-07-01
136165	2050170264	K911419	SENSITITRE ARIS MODULE	LRG	1992-07-01
7644	1773476268	K910526	MICROTEST MULTI MICROBE MEDIUM	JSM	1991-04-09
7644	1004469470	K910180	BACTI-SWAB	JSM	1991-05-10
7644	1142245552	K905472	LAP DISCS	JTO	1991-02-27
38116	1142245552	K905472	LAP DISCS	JTO	1991-02-27
7644	1785362809	K905163	NITRATE DISK	JTO	1991-02-20
38116	1785362809	K905163	NITRATE DISK	JTO	1991-02-20
7644	1469548910	K905151	VANCOMYCIN DISK-5 MCG	JTO	1991-01-25
38116	1469548910	K905151	VANCOMYCIN DISK-5 MCG	JTO	1991-01-25
7644	1261725875	K902595	CATARRHALIS TEST STRIP	JTO	1990-10-02
38116	1261725875	K902595	CATARRHALIS TEST STRIP	JTO	1990-10-02
7644	1735759108	K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	1990-06-28
38116	1735759108	K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	1990-06-28
7644	2051387085	K900517	RAPID NF SYSTEM	JSW	1990-03-13
38116	2051387085	K900517	RAPID NF SYSTEM	JSW	1990-03-13
7644	1901049504	K894848	HAEMOPHILUS TEST MEDIUM (BROTH)	JSO	1989-09-06
7644	1875986622	K892928	HAEMOPHILUS TEST MEDIUM (AGAR)	JSO	1989-06-13
7644	1481852142	K891476	C. ALBICANS SCREEN	JXC	1989-04-12
38116	1481852142	K891476	C. ALBICANS SCREEN	JXC	1989-04-12
7644	1361313744	K884720	GERM TUBE SOLUTION	JXC	1989-06-02
7644	1170961805	K883641	SELECTIVE RAPID UREA	LYR	1989-05-04
7644	1218986157	K882960	IDS RAPID ANA SYSTEM	JSP	1988-08-12
38116	1218986157	K882960	IDS RAPID ANA SYSTEM	JSP	1988-08-12
7644	1084749167	K882636	ALN DISCS	JTO	1989-02-16
38116	1084749167	K882636	ALN DISCS	JTO	1989-02-16
7644	1453663438	K882630	PRO DISCS	JTO	1989-02-16
38116	1453663438	K882630	PRO DISCS	JTO	1989-02-16
7644	1111379052	K881995	DIAMOND'S MEDIUM MODIFIED	KZI	1988-06-02
7644	2034310008	K881501	MODIFIED IDS RAPID NH SYSTEM	JSX	1988-05-18
38116	2034310008	K881501	MODIFIED IDS RAPID NH SYSTEM	JSX	1988-05-18
7644	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
38116	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
7644	1781343478	K880950	PYR/ESCULIN DISK	JTO	1988-04-01
38116	1781343478	K880950	PYR/ESCULIN DISK	JTO	1988-04-01
7644	1925511247	K880717	SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR	JSJ	1988-03-03
7644	2015446776	K880716	SLIDE CULTURE PLATE-POTATO FLAKE AGAR	JSJ	1988-03-03
7644	1990038342	K872189	METHANOL, ABSOLUTE	JTS	1987-07-29
7644	1807524970	K872188	MACCONKEY W/SORBITOL	JSI	1987-06-24
7644	1504959940	K872187	TB KINYOUN CARBOLFUCHSIN	JTS	1987-07-29
7644	1125260114	K872186	SULFURIC ACID 10%	JTS	1987-07-29
7644	1130916701	K872185	LIGHT GREEN	JTS	1987-07-29
7644	1537396937	K872184	TB METHYLENE BLUE	JTS	1987-07-29
7644	1911153593	K871447	TODD HEWITT W/CNA (LIM BROTH)	JSD	1987-05-13
7644	1181023245	K871286	GRAM IODINE	HYI	1987-04-08
7644	1381379123	K864205	THERMONUCLEASE AGAR W/TOLUIDINE BLUE	JSH	1986-11-24
7644	1251945191	K863216	NEIS NZY	JTO	1986-09-15
38116	1251945191	K863216	NEIS NZY	JTO	1986-09-15
7644	1226423355	K861259	MACCONKEY W/MUG	JTO	1986-04-11
7644	1633213249	K860707	OFPBL	JSI	1986-03-11
7644	1502605154	K860302	PYR DISCS	JTO	1986-02-05
38116	1502605154	K860302	PYR DISCS	JTO	1986-02-05
7644	1731865659	K852886	MUG DISK	JTO	1985-07-23
38116	1731865659	K852886	MUG DISK	JTO	1985-07-23
7644	1879282909	K852871	IDS RAPID SS/U SYSTEM	JSS	1985-07-23
38116	1879282909	K852871	IDS RAPID SS/U SYSTEM	JSS	1985-07-23
7644	1181239673	K852110	IDS RAPID E PLUS SYSTEM	JSS	1985-06-04
38116	1181239673	K852110	IDS RAPID E PLUS SYSTEM	JSS	1985-06-04

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
JTO	82	1996-10-08
JSJ	10	1988-03-03
JWY	9	2025-09-05
JTS	9	1996-03-19
JSO	8	2017-05-01
JSM	8	1997-01-22
JSS	8	1985-07-23
JSI	7	1987-06-24
JXB	6	1995-01-27
LIO	5	2001-11-26
LRG	4	2011-09-22
JTZ	4	1996-03-25
JSX	4	1992-11-02
KTN	4	1990-06-28
JSF	4	1985-04-22
NGZ	3	2014-01-31
JXC	3	1989-06-02
LIE	2	2011-06-22
PSZ	2	2009-08-26
MHI	2	2003-11-18
MDB	2	2003-08-22
JWX	2	1997-02-07
GNA	2	1994-04-20
GMD	2	1994-02-17
LJZ	2	1992-06-29
JSW	2	1990-03-13
JSP	2	1988-08-12
HYI	2	1987-04-08
MJD	2	1984-03-23
JSN	2	1983-12-30
JTC	2	1980-07-21
MJE	1	2007-11-26
JTW	1	2006-06-23
MJA	1	2006-01-19
LLH	1	2004-11-15
MHJ	1	2003-11-14
GQG	1	2003-01-29
LIQ	1	1999-08-09
JTY	1	1996-02-16
JSL	1	1995-02-16