Product code KIP

Device name: Formulations, Balanced Salt Solutions
Medical specialty: Hematology
Device class: 1
Regulation number: 864.2875
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K870491	KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002	Sigma Chemical Co.	1987-03-30
K870486	EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509	Sigma Chemical Co.	1987-03-30
K870484	HANKS' BALANCED SALTS (HBSS) NO. H1387	Sigma Chemical Co.	1987-03-30
K870482	(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030	Sigma Chemical Co.	1987-03-30
K860784	DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2	Tissue Culture Innovations	1986-03-12
K844878	TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG	Hazleton Research Products, Inc.	1985-02-25
K844877	HEPES BUFFER IM IN NORMAL SALINE	Hazleton Research Products, Inc.	1985-02-25
K842724	SALINE 0.85% W/O PRESERVATIVE	E K Ind., Inc.	1984-08-03
K842725	SALINE, 0.85%W/PRESERVATIVE	E K Ind., Inc.	1984-08-03
K842723	SALINE, 1.3% W/O PRESERVATIVE	E K Ind., Inc.	1984-08-03
K820928	EBS POWDER	Dutchland Laboratories, Inc.	1982-04-21
K820927	HBS POWDER	Dutchland Laboratories, Inc.	1982-04-21
K820923	DULBECCO'S PBS POWDER	Dutchland Laboratories, Inc.	1982-04-21
K810779	EARLE'S BALANCED SALTS SOULTION	Dutchland Laboratories, Inc.	1981-05-13
K810777	HANKS' BALANCED SALTS SOLUTION (MODIF.)	Dutchland Laboratories, Inc.	1981-05-08
K810766	HANKS' BALANCED SALT SOLUTION W/O CA-MG	Dutchland Laboratories, Inc.	1981-05-08
K781391	PBS FOR FA (46-991-49)	Flow Laboratories, Inc.	1978-08-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10190302002714	Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002851	Hanks’ Balanced Salt Solution (HBSS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002899	Hanks’ Balanced Salt Solution (HBSS) (10X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002820	Hanks’ Balanced Salt Solution (HBSS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002813	Hanks’ Balanced Salt Solution (HBSS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002776	Dulbecco’s Phosphate Buffered Saline (D-PBS) (10X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002752	Hanks’ Balanced Salt Solution (HBSS) (10X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002929	Dulbecco's Phosphate Buffered Saline (D-PBS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002707	Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302003001	Dulbecco's Phosphate Buffered Saline (D-PBS) (10X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002660	Hanks’ Balanced Salt Solution (HBSS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302001069	Phosphate-Buffered Saline (PBS) (1X), pH 7.4	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302003339	Phosphate-Buffered Saline (PBS) (1X), pH 7.2	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302003865	Hanks’ Balanced Salt Solution (HBSS) (1X)	LIFE TECHNOLOGIES LIMITED	2023-10-02
10190302002837	Hanks' Balanced Salt Solution (HBSS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302003018	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302003322	Phosphate Buffered Saline (PBS), PH 7.2	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302002875	Hanks' Balanced Salt Solution (HBSS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302002844	Hanks' Balanced Salt Solution (HBSS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302002721	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302002684	Hanks' Balanced Salt Solution (HBSS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302002677	Hanks' Balanced Salt Solution (HBSS)	LIFE TECHNOLOGIES CORPORATION	2016-08-04
10190302000628	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-01
10190302002912	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES LIMITED	2016-08-01
10190302002950	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-01
10190302001076	Phosphate Buffered Saline (PBS), PH 7.4	LIFE TECHNOLOGIES CORPORATION	2016-08-01
10190302001052	Phosphate Buffered Saline (PBS), PH 7.4	LIFE TECHNOLOGIES CORPORATION	2016-08-01
10190302003438	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-01
10190302003445	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES LIMITED	2016-08-01
10190302000635	Dulbecco's Phosphate Buffered Saline (D-PBS)	LIFE TECHNOLOGIES CORPORATION	2016-08-01

Product code KIP

Related 510(k) Records#

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