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Company · US

Pyramid Biological Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1997. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	3
GOM	Antisera, Cf, Rubella	2
GQI	Antiserum, Cf, Cytomegalovirus	2
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	2
GMM	Antigens, Iha, Toxoplasma Gondii	1
LYR	Helicobacter Pylori	1
MJY	Kit, Serological, Negative Control	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jan 27, 1997	K964675	H.PYLORI CONTROLS Pyramid Biological Corp.	LYR
Aug 2, 1996	K962399	HEPATITIS NEGATIVE CONTROL Pyramid Biological Corp.	MJY
Jun 24, 1996	K961317	SYPHILIS IGM HUMAN SERUM CONTROLS Pyramid Biological Corp.	LIP
Jun 17, 1996	K960493	SYPHILIS IGG HUMAN SERUM CONTROLS Pyramid Biological Corp.	LIP
Dec 20, 1995	K954515	ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA Pyramid Biological Corp.	GOM
Dec 14, 1995	K953826	ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA Pyramid Biological Corp.	GOM
Nov 20, 1995	K952818	ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII Pyramid Biological Corp.	GMM
Nov 16, 1995	K952254	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS Pyramid Biological Corp.	GQI
Nov 16, 1995	K951800	CMV IGG HUMAN SERUM CONTROLS Pyramid Biological Corp.	GQI
Nov 17, 1994	K944515	SERUM PROTEIN CONTROLS Pyramid Biological Corp.	JJX
Feb 17, 1994	K933218	REFRACTOMETRIC, TOTAL PROTEIN Pyramid Biological Corp.	JJX
Dec 2, 1993	K932479	B-HCG HUMAN SERUM CONTROLS Pyramid Biological Corp.	JJX

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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